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Found 568 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: 455351 (history)  
Form: Version 1.0  
Age: 0.24  
Sex: Male  
Location: Foreign  
Vaccinated:2012-03-26
Onset:2012-04-03
   Days after vaccination:8
Submitted: 2012-05-10
   Days after onset:37
Entered: 2012-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Intestinal resection, Intussusception, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Hypersensitivity (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Urticaria
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0800130A

Write-up: This case was reported by a physician via regulatory authority (# 165434) and described the occurrence of ileocolic intussusception in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline) and INFANRIX. Concurrent medical conditions included urticaria. On 26 March 2012, the subject received an unspecified dose of ROTARIX (oral, batch number not provided) and an unspecified dose of INFANRIX (administration site and route unknown, batch number not provided). On 2 April 2012, the subject was treated with tinset for urticaria. On 3 April 2012, 1 day after treatment with tinset, 8 days after vaccination with INFANRIX and ROTARIX, the subject experienced ileocolic intussusception. The subject was hospitalised. A resection of intestine was performed. At the time of reporting the event was resolved with the following sequelae (intestine resection). The regulatory authority reported that the event was possibly related to vaccination with ROTARIX and INFANRIX.


VAERS ID: 455696 (history)  
Form: Version 1.0  
Age: 0.27  
Sex: Male  
Location: Foreign  
Vaccinated:2012-04-06
Onset:2012-04-15
   Days after vaccination:9
Submitted: 2012-05-16
   Days after onset:31
Entered: 2012-05-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Adenovirus test, Alanine aminotransferase normal, Albumin globulin ratio, Amylase decreased, Aspartate aminotransferase normal, Basophil percentage decreased, Blood albumin decreased, Blood alkaline phosphatase increased, Blood bilirubin normal, Blood chloride increased, Blood creatine phosphokinase normal, Blood creatinine decreased, Blood glucose increased, Blood lactate dehydrogenase increased, Blood potassium normal, Blood sodium normal, Blood urea decreased, C-reactive protein normal, Crying, Enema administration, Eosinophil percentage, Flatulence, Gamma-glutamyltransferase normal, Haematochezia, Haematocrit normal, Haemoglobin normal, Intussusception, Irritability, Laboratory test abnormal, Lymphocyte percentage increased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin decreased, Mean cell volume decreased, Megacolon, Monocyte percentage, Mood altered, Mucous stools, Neutrophil percentage decreased, Platelet count decreased, Protein total decreased, Red blood cell count increased, Red cell distribution width increased, Rotavirus test negative, Ultrasound abdomen abnormal, White blood cell count normal, X-ray abnormal
SMQs:, Liver related investigations, signs and symptoms (broad), Agranulocytosis (broad), Haematopoietic leukopenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Biliary system related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Depression (excl suicide and self injury) (broad), Tubulointerstitial diseases (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? 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, 19Apr2012, see text; Alanine aminotransferase, 19Apr2012, 30IU/L; Albumin, 19Apr2012, 3.9g/dL; Albumin globulin ratio, 19Apr2012, 2.17; Alkaline phosphatase, 19Apr2012, 1096IU/L; Amylase, 19Apr2012, 15IU/L; Aspartate aminotransferase, 19Apr2012, 36IU/L; Basophils, 19Apr2012, 0.4%; Bilirubin total, 19Apr2012, 0.47mg/dL; Blood glucose, 19Apr2012, 104mg/dL; Blood urea nitrogen, 19Apr2012, 4.2mg/dL; C-reactive protein, 19Apr2012, 0mg/dL; Chloride, 19Apr2012, 111mEq/L; Creatine phosphokinase, 19Apr2012, 112IU/L; Creatinine, 19Apr2012, 0.17mg/dL; Echography, 19Apr2012, see text; Eosinophils, 19Apr2012, 2.3%; Gamma glutamyl transpeptidase, 19Apr2012, 17IU/L; Hematocrit, 19Apr2012, 35.3%; Hemoglobin, 19Apr2012, 11.9g/dL; Lactate dehydrogenase, 19Apr2012, 259IU/L; Lymphocytes, 19Apr2012, 80.8%; Mean cell hemoglobin, 19Apr2012, 26.3pg; Mean cell hemoglobin concentra, 19Apr2012, 33.7g/dL; Mean cell volume, 19Apr2012, 77fL; Monocytes, 19Apr2012, 3.7%; Neutrophils, 19Apr2012, 12.8%; Platelet count, 19Apr2012, 40.1x10^4/mm3; Potassium, 19Apr2012, 4.2mEq/L; Protein total, 19Apr2012, 5.7g/dL; Red blood cell count, 19Apr2012, 453x10^4/mm3; Red cell distribution width, 19Apr2012, 34.9fL; Sodium, 19Apr2012, 137mEq/L; White blood cells, 19Apr2012, 71x10^2/mm3
CDC Split Type: B0797641A

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 liquid formulation (GlaxoSmithKline). On April 6 2012 the subject received unspecified dose of ROTARIX liquid formulation (oral). On 15 April 2012, 9 days after vaccination with ROTARIX liquid formulation, the subject fretted once every hour. On 19 April 2012, 13 days after vaccination with ROTARIX liquid formulation, the subject experienced invagination of intestine and bloody stools with a bad mood intermittently. The subject was hospitalised. The subject was treated with enema and the invagination of intestine was reduced. On 20 April 2012, invagination of intestine was resolved. At the time of reporting, the outcome bad mood and bloody stools was unspecified. The physician considered invagination of intestine was related to vaccination with ROTARIX liquid formulation. Follow-up information received on 7 May 2012: No family history of intussusception or intestinal abnormality, no history of any intra-abdominal surgery, no congenital intestinal malformation, no Intestinal polyp, no Meckel''s diverticulum, no intestinal vascular malformation, no cystic fibrosis, no Hirschsprung''s disease, no other gastrointestinal malformation and dysfunction, no invagination. On 6 April 2012, the subject received 1st dose of ROTARIX liquid formulation. On 15 April 2012, 9 days after vaccination with ROTARIX liquid formulation, the subject experienced bad mood and crying. The way he took breast milk was unchanged, so that he was just placed under observation. On 16 April 2012, the subject''s mood improved and his condition turned to usual normality. On 19 April 2012, 13 days after vaccination with ROTARIX liquid formulation, the subject excreted mucous blood stools. Because he presented with intermittent fretfulness and crying, he visited another hospital for consultation and was suspected to sustain invagination of intestine. He received glycerin enema at the emergency outpatient department of the reporting physician''s hospital, and was found to have mucous bloody stools. Abdominal echography and plain radiography were performed. The patient received abdominal X-ray with high-pressure enema with 5-times-diluted GASTROGRAFIN. Before implementation of the high-pressure enema, a drip infusion route was secured, fluid replacement was initiated, and consequently the patient stopped crying. In addition, his abdomen turned soft about when he underwent sedation procedure before the high-pressure enema was initiated. Although the high-pressure enema showed slight retention of the contrast media (5-times-diluted GASTROGRAFIN) in the region from hepatic flexure to ascending colon, no apparent sign of crab''s claw pattern was noted and thereafter a smooth inflow into the small intestine proceeded. These result suggested a possibility that spontaneous reduction occurred immediately before the high enema was performed. Relevant tests results performed on 19 April 2012: Alanine aminotransferase: 30 IU/L; Albumin: 3.9 g/dL; Albumin globulin ratio: 2.17; Alkaline phosphatase: 1096 IU/L; Amylase: 15 IU/L; Aspartate aminotransferase: 36 IU/L; Blood urea nitrogen: 4.2 mg/dL; C-reactive protein: 0 mg/dL; Chloride: 111 mEq/L; Creatine phosphokinase: 112 IU/L; Creatinine: 0.17 mg/dL; Eosinophils: 2.3 %; Gamma glutamyl transpeptidase: 17 IU/L; Hematocrit: 35.3 %; Hemoglobin: 11.9 g/dL; Hemolysis: negative, Lactate dehydrogenase: 259 IU/L; Lymphocytes: 80.8 %; Mean cell hemoglobin: 26.3 pg; Mean cell hemoglobin concentration: 33.7 g/dL; Mean cell volume: 77 fL; Monocytes: 3.7 %; Neutrophils: 12.8 %; Platelet count: 40.1 x10^4/mm3; Potassium: 4.2 mEq/L; Protein total: 5.7 g/dL; Red blood cell count: 453 x10^4/mm3; Red cell distribution width: 34.9 fL; Sodium: 137 mEq/L; White blood cells: 71 x10^2/mm3. On abdominal echography, a target sign was observed positive in the right lower abdomen. On abdominal radiography, a plain abdominal radiographic examination showed colectasia due to accumulation of intestinal gas. The chyle was positive (4+). Between 19 and 21 April 2012, there were not significant blood matters in the collected fluid. A possibility of spontaneous reduction was also considered. The subject received fluid replacement and underwent approximately a half-day fasting and intestinal rest, and subsequently he took breast milk little by little. On 20 April 2012, Rotavirus stool antigen and Adenovirus stool antigen were negative. Between 21 and 23 April 2012, he took breast milk well and bloody stool was no more observed. He presented with no fretfulness. The subject was discharged from the hospital on 23 April 2012. On plain abdominal X-ray/ enema of air or contrast media, there was no confirmation of visible invagination of intestine or soft tissue mass on plain abdominal X-ray nor of findings of invagination of intestine with enema of air or contrast medium. The niveau and distended intestinal loops on plain abdominal X-ray and nonspecific abnormalities on plain abdominal X-ray were confirmed. On abdominal ultrasound echography there was no confirmation of visible invagination or soft tissue mass on abdominal ultrasound echography. The target sign or a doughnut sign on the transverse section image and a pseudo-kidney sign or a sandwich sign on the transverse section was confirmed. No abdominal CT scanning was performed to confirmed of visible intussusception or soft tissue mass on abdominal CT scanning. No surgery was required. There was no complication with x-ray procedure. At the time of reporting, the events were resolved.


VAERS ID: 456939 (history)  
Form: Version 1.0  
Age: 0.35  
Sex: Female  
Location: Foreign  
Vaccinated:2012-05-09
Onset:2012-05-13
   Days after vaccination:4
Submitted: 2012-06-06
   Days after onset:24
Entered: 2012-06-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Enteritis, Gastrointestinal oedema, Haematochezia, Intussusception, Rotavirus test negative, Small intestinal intussusception reduction, Ultrasound abdomen abnormal, Vaccination complication
SMQs:, Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific inflammation (narrow), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Rotavirus test, 14May2012, Negative; Ultrasound abdomen, 13May2012, invagination of
CDC Split Type: B0802121A

Write-up: This case was reported by a physician and described the occurrence of invagination of intestine in a 19-week-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included 1st dose of ROTARIX, given on 10 April 2012. On 9 May 2012, the subject received 2nd dose of ROTARIX (1.5 ml, oral, batch number not provided). On 13 May 2012, 4 days after vaccination with ROTARIX, bloody stool was observed after the anus was stimulated with a cotton swab. On 14 May 2012, the subject presented with bloody stool twice. The reduction of invagination was performed. A rapid test for rotavirus in stool was negative. The subject was hospitalised. On 14 May 2012, the event bloody stools resolved and at the time of reporting the event invagination of intestine was improved. The physician considered the events were related to vaccination with ROTARIX. Judging from the time course, it was possible that the event was an adverse reaction to the rotavirus vaccine. Additional information received on 01 June 2012: On an unknown date, the subject was observed swelling of the small-intestinal wall and Enteritis.


VAERS ID: 457352 (history)  
Form: Version 1.0  
Age: 0.38  
Sex: Female  
Location: Foreign  
Vaccinated:2012-02-09
Onset:2012-06-03
   Days after vaccination:115
Submitted: 2012-06-13
   Days after onset:10
Entered: 2012-06-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / SC
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Diarrhoea, Echography abnormal, Functional gastrointestinal disorder, Gastrointestinal surgery, Haematochezia, Intussusception
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0807418A

Write-up: This case was reported by a physician and described the occurrence of invagination of intestine in a 8-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included DTP (a or w not known) vaccine (non-GSK manufacturer) given on 10 January 2012 and 9 February 2012; Hib vaccine (non-GSK manufacturer) given on 10 January 2012 and 9 February 2012; ROTARIX (GlaxoSmithKline) given on 10 January 2012; pneumococcal vaccines (non-GSK manufacturer) given on 9 February 2012. On 9 February 2012 the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 3 June 2012, 115 days after vaccination with ROTARIX, the subject experienced bloody stools and intestinal functional disorder. No vomited occurred. The subject was hospitalised and invagination of intestine was diagnosed by echography. The subject was treated with surgery (reduction of intussusception). On 5 June 2012, the subject was discharged. Invagination of intestine was resolved but a mild diarrhea persisted. At the time of reporting the events were unresolved. The physician considered the events were unrelated to vaccination with ROTARIX since several months had passed after the vaccination.


VAERS ID: 457540 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2012-06-04
Onset:2012-06-04
   Days after vaccination:0
Submitted: 2012-06-15
   Days after onset:11
Entered: 2012-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / SC
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal rigidity, Diarrhoea, Haematochezia, Intussusception
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0807415A

Write-up: This case was reported by a physician and described the occurrence of bloody stools in a 9-week-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included influenzae type b vaccine (non-gsk) ;non-GSK manufacturer; subcutaneous;unknown given on 4 June 2012; pneumococcal vaccines (non-gsk) ;non-GSK manufacturer; subcutaneous; unknown given on 4 June 2012. On 4 June 2012, the subject received an unspecified dose of ROTARIX (1.5 ml, oral). On 7 June 2012, 3 days after vaccination with ROTARIX, the subject experienced bloody stools, abdominal rigidity (right side of the lower abdomen) and diarrhea. Invagination of intestine was suspected. He was transferred to another hospital. It was unknown if the subject was hospitalised. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting, the outcome of the events was unspecified.


VAERS ID: 457689 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Foreign  
Vaccinated:2012-04-27
Onset:2012-05-07
   Days after vaccination:10
Submitted: 2012-06-19
   Days after onset:43
Entered: 2012-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SC
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA414AA / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Diarrhoea, Faeces discoloured, Haematochezia, Intussusception, Nasal congestion, Pyrexia, Rhinorrhoea, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0808468A

Write-up: This case was reported by a physician and described the occurrence of invagination of intestine in a 24-week-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included bacillus calmette-guerin vaccine (non-gsk);non-GSK manufacturer;subcutaneous given on 27 April 2012; haemophilus influenzae type b vaccine (non-gsk);non-GSK manufacturer;subcutaneous given on 30 March 2012; ROTARIX;GlaxoSmithKline;oral given on 30 March 2012. On 27 April 2012, the subject received 2nd dose of ROTARIX (0.5 ml, oral). On 7 May 2012, 10 days after vaccination with ROTARIX, the subject experienced watery diarrhea and stool discolored. On 13 May 2012, 16 days after vaccination with ROTARIX, the subject experienced vomiting, fever, nasal discharge and nasal congestion. On 22 May 2012, 25 days after vaccination with ROTARIX, the subject experienced bloody stools. On 2 June 2012, 36 days after vaccination with ROTARIX, the diagnosis of invagination of intestine was made. The subject was hospitalised. The subject was treated with antidiarrheal, antibiotics, cold medication, anti-emetic. On 4 June 2012, invagination of intestine and bloody stools were resolved. The subject was discharged from hospital. At the time of reporting, the other events were resolved. The physician considered the events were related to vaccination with ROTARIX.


VAERS ID: 457838 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2012-04-10
Onset:2012-05-11
   Days after vaccination:31
Submitted: 2012-06-21
   Days after onset:41
Entered: 2012-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Adenovirus test, Alanine aminotransferase normal, Albumin globulin ratio, Amylase normal, Aspartate aminotransferase normal, Band neutrophil count decreased, Basophil percentage, Blood albumin decreased, Blood alkaline phosphatase increased, Blood bicarbonate normal, Blood bilirubin decreased, Blood calcium normal, Blood chloride normal, Blood creatine phosphokinase normal, Blood creatinine decreased, Blood glucose normal, Blood ketone body increased, Blood lactate dehydrogenase normal, Blood pH decreased, Blood phosphorus normal, Blood potassium decreased, Blood sodium normal, Blood urea decreased, Blood uric acid increased, C-reactive protein increased, Carbon dioxide normal, Culture stool negative, Enema administration, Eosinophil percentage increased, Gamma-glutamyltransferase normal, Haematochezia, Haematocrit decreased, Haemoglobin normal, Intussusception, Laboratory test normal, Lymphocyte percentage increased, Mean cell haemoglobin concentration decreased, Mean cell haemoglobin decreased, Mean cell volume normal, Mean platelet volume decreased, Monocyte percentage, Neutrophil percentage decreased, Oxygen saturation decreased, PO2 decreased, Platelet count increased, Protein total decreased, Red blood cell count, Red cell distribution width normal, Rotavirus test negative, Ultrasound abdomen abnormal, Vomiting, White blood cell count normal
SMQs:, Liver related investigations, signs and symptoms (broad), Acute pancreatitis (broad), Agranulocytosis (broad), Asthma/bronchospasm (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Lactic acidosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Myelodysplastic syndrome (broad), Noninfectious diarrhoea (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Hypokalaemia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Adenovirus test, 11May2012, NEGATIVE; Alanine aminotransferase, 11May2012, 26IU/L; Alanine aminotransferase, 12May2012, 23IU/L; Albumin, 11May2012, 4.7g/dL; Albumin, 12May2012, 4.1g/dL; Albumin globulin ratio, 11May2012, 2.4; Albumin globulin ratio, 12May2012, 2.3; Alkaline phosphatase, 11May2012, 539IU/L; Alkaline phosphatase, 12May2012, 538IU/L; Amylase, 11May2012, 51U/L; Amylase, 12May2012, 72U/L; Aspartate aminotransferase, 11May2012, 28IU/L; Aspartate aminotransferase, 12May2012, 28IU/L; Band neutrophil count, 11May2012, 0%; Band neutrophil count, 12May2012, 0%; Basophils, 11May2012, 0.5%; Basophils, 12May2012, 0.5%; Bicarbonate, 11May2012, 19.5mmol/L; Bilirubin total, 11May2012, 0.3mg/dL; Bilirubin total, 12May2012, 0.2mg/dL; Blood glucose, 11May2012, 76mg/dL; Blood pressure, 11May2012, 82/54mmHg; Blood urea nitrogen, 11May2012, 15mg/dL; Blood urea nitrogen, 12May2012, 3mg/dL; Body temperature, 11May2012, 36.6deg.C; Body temperature, 12May2012, 37.1deg.C; C-reactive protein, 11May2012, 2.4mg/dL; C-reactive protein, 12May2012, 1mg/dL; Calcium, 11May2012, 10.6mg/dL; Calcium, 12May2012, 10.4mg/dL; Carbon dioxide total, 11May2012, 106mEq/L; Chloride, 11May2012, 106mEq/L; Chloride, 12May2012, 107mEq/L; Creatine phosphokinase, 11May2012, 42U/L; Creatine phosphokinase, 12May2012, 46U/L; Creatinine, 11May2012, 0.17mg/dL; Creatinine, 12May2012, 0.18mg/dL; Eosinophils, 11May2012, 0%; Eosinophils, 12May2012, 10.5%; Fasting blood glucose, 11May2012, 71mg/dL; Gamma glutamyl transpeptidase, 11May2012, 18IU/L; Gamma glutamyl transpeptidase, 12May2012, 16IU/L; Hematocrit, 11May2012, 33%; Hematocrit, 12May2012, 33%; Hemoglobin, 11May2012, 11.3g/dL; Hemoglobin, 12May2012, 10.2g/dL; Lactate dehydrogenase, 11May2012, 213IU/L; Lactate dehydrogenase, 12May2012, 219IU/L; Lymphocytes, 11May2012, 36.5%; Lymphocytes, 12May2012, 64.5%; Mean cell hemoglobin, 11May2012, 27.7pg; Mean cell hemoglobin, 12May2012, 25.5pg; Mean cell hemoglobin concentra, 11May2012, 34.1%; Mean cell hemoglobin concentra, 12May2012, 30.9%; Mean cell volume, 11May2012, 81.3fL; Mean cell volume, 12May2012, 82.4fL; Monocytes, 11May2012, 7%; Monocytes, 12May2012, 4%; Neutrophils, 11May2012, 56%; Neutrophils, 11May2012, 5656; Neutrophils, 12May2012, 20%; Phosphorus, 11May2012, 4.8mg/dL; Phosphorus, 12May2012, 4.8mg/dL; Platelet count, 11May2012, 50.4x10^4/mcL; Platelet count, 12May2012, 44.1x10^4/mcL; Potassium, 11May2012, 5mEq/L; Potassium, 12May2012, 3.7mEq/L; Protein total, 11May2012, 6.7g/dL; Protein total, 12May2012, 5.9g/dL; Pulse rate, 11May2012, 100/min; Pulse rate, 12May2012, 132/min; Red blood cell count, 11May2012, 406x10^54/mcL; Red blood cell count, 12May2012, 401X10^54/mcL; Red cell distribution width, 11May2012, 13.1%; Red cell distribution width, 12May2012, 13.1%; Rotavirus test, 11May2012, NEGATIVE; Segmented neutrophil count, 11May2012, 56%; Segmented neutrophil count, 12May2012, 20%; Sodium, 11May2012, 140mEq/L; Sodium, 12May2012, 143mEq/L; Stool culture, 11May2012, NEGATIVE; Ultrasound abdomen, 11May2012, INTUSSUSCEPTION; Uric acid, 11May2012, 7.0mg/dL; Uric acid, 12May2012, 3.1mg/dL; White blood cells, 11May2012, 10100/mcL; White blood cells, 12May2012, 8000/mcL; pH, 11May2012, 7.338; 11 May 2012: Norovirus stools test: negative.
CDC Split Type: B0804208A

Write-up: This case was reported by a physician and described the occurrence of invagination of intestine in a 17-week-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included DTaP, given on 10 April 2012, Hib (non-gsk), given on 12 March 2012, SYNFLORIX, given on 12 March 2012 and the 1st dose of ROTARIX, given on 12 March 2012. On 10 April 2012, the subject received the 2nd dose of ROTARIX (1.5 ml, oral, batch number not provided). On 11 May 2012, 31 days after vaccination with ROTARIX, the subject began to have invagination of intestine and was admitted to the hospital. On an unspecified date, the subject recovered from the event and was discharged. The subject was hospitalised. The reporting physician considered unlikely that ROTARIX was the cause of the event, because the invagination of intestine developed 1 month after the second vaccination of the drug, and in addition, invagination of intestine could occasionally develop in infants who received no vaccination. Additional information received on 01 June 2012: On 10 May 2012, at 9:00, the subject experienced vomiting frequently. On 10 May 2012, at 15:00, the subject had bloody stools. On 11 May 2012, at 11:00, after the consultation with the previous physician, the subject was referred to the reporting hospital. The subject was suspected of having invagination of intestine and manipulation was performed after abdominal ultrasound. The intestinal intussusception reduction was done promptly. On 11 May 2011, test for stool rotavirus antigen, adenovirus, and Norovirus were all negative and stool cultures was negative. On 12 May 2012, at 13:00, the subject was discharged from the hospital without recurrence. On 15 May 2012, at 11:00, the subject visited the hospital after the discharge. It was confirmed that the subject had no problems at home either and thus the follow-up was completed. Findings with enema of air or contrast medium confirmed intussusception. There was no family history of intussusception or intestinal abnormality, past laparoscopic surgery, congenital intestinal malformation, or intussusception. Abnormality disappeared with enema of contrast media/fluid pressure/air. The causal relationship to ROTARIX was unknown, since the invagination of intestine itself was not rare for the subject''s age. However, it could not be ruled out completely. Additional information received on 12 June 2011: On 10 April 2012, the subject received the 2nd dose of ROTARIX (batch number was provided). on 11 May 2012, laboratory results showed CRP increased (2.4 mg/dL), albumin globulin ratio abnormal (2.4), creatine phosphokinase decreased (42 U/L), alkaline phosphatase increased (539 U/L), creatinine low (0.17 mg/dL), high potassium (5.0), high calcium (10.6), blood ketone body increased, white blood cell count high (10100/mcL), low haemoglobin (10.2 g/dL), low haematocrit (33%), mean cell volume low (81.3 fL), mean cell haemoglobin low (27.7 pg), increased platelet count (50.4 x10^4/mcL), mean platelet volume decreased, pH decreased (7.338), decreased PO2, carbon dioxide total decreased (27.1 mmHg), decreased oxygen saturation, total protein decreased (5.9 g/dl). On 12 May 2012, laboratory results showed blood urea nitrogen decreased (3 mg/dL) and decreased uric acid (3.1 mg/dL). On 11 May 2012, the events bloody stools and vomiting resolved. On 12 May 2012, the event invagination of intestine had resolved. No further information is available for this case. This case is closed.


VAERS ID: 459662 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Male  
Location: Foreign  
Vaccinated:2012-05-08
Onset:2012-05-12
   Days after vaccination:4
Submitted: 2012-07-19
   Days after onset:68
Entered: 2012-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA490AA / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal mass, Alanine aminotransferase normal, Base excess negative, Blood calcium normal, Blood creatinine normal, Blood glucose normal, Blood pH normal, Blood potassium normal, Blood sodium normal, Blood urea normal, C-reactive protein normal, Crying, Decreased appetite, Diarrhoea, Enema administration, Gastrointestinal examination normal, General physical health deterioration, Haemangioma, Haematocrit normal, Haemoglobin normal, Hypersomnia, Hypophagia, Intussusception, Mesenteric lymphadenopathy, Opisthotonus, PCO2 normal, Platelet count normal, Restlessness, Ultrasound abdomen abnormal, White blood cell count normal
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Akathisia (broad), Dystonia (narrow), Gastrointestinal obstruction (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (narrow), 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? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hemangioma; Petechiae on back
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Alanine aminotransferase, 13May2012, normal; Base excess, 13May2012, -2.8mmHg; Blood calcium, 13May2012, normal; Blood creatinine, 13May2012, normal; Blood glucose, 13May2012, normal; Blood potassium, 13May2012, normal; Blood pressure, 13May2012, 100/47mmHg; Blood sodium, 13May2012, normal; Blood urea, 13May2012, normal; Body temperature, 13May2012, 36.8degC; C-reactive protein, 13May2012, 0.2mg/dl; Heart rate, 13May2012, 100/min; Hematocrit, 13May2012, 39.1%; Hemoglobin, 13May2012, 12.1g/dl; PCO2, 13May2012, 41.0mmHg; Platelet count, 13May2012, 474/nl; Ultrasound abdomen, 13May2012, pathologic; Ultrasound abdomen, 14May2012, improved; White blood cell count, 13May2012, 5.83/nl; pH, 13May2012, 7.34
CDC Split Type: D0075928A

Write-up: This case was reported by a physician via a sales representative and described the occurrence of intussusception of intestine in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 08 May 2012 the subject received the first dose of ROTARIX (1.5 ml, oral). Approximately five days post vaccination with ROTARIX, on 13 May 2012, the subject experienced intussusception of intestine and was hospitalised for an unknown period of time. The course of the event was without complications. At the time of reporting the outcome of the event was unspecified. Follow-up information including a hospital report was received on 13 July 2012 from the reporting physician. The subject has no underlying or concurrent medical conditions or other risk factors. No concomitant medication has been reported. On 08 May 2012 the subject received the first dose of ROTARIX (1.5 ml, oral). Approximately five days post vaccination with ROTARIX, on 13 May 2012, the subject experienced intussusception of intestine. The subject was hospitalised for three days. According to anamnesis in hospital the subject was restless since 13 May 2012 in the morning. The subject experienced opisthotonus and persistent crying, followed by a phase of calming down and falling asleep. More or less the subject was sleeping all day long. The subject did not demand food as normally. During 13 May 2012 the subject was drinking 100 to 200 ml only. The diapers contained lots of urinary discharge. The subject did not experience fever. The last stool had been thin and was dejected on the previous day, on 12 May 2012. Stool did not contain any blood. On 13 May 2012 the subject has not had any stools. On admission to hospital the subject was in reduced general condition. Turgor was balanced, mucous membranes were humid. The subject was persistently crying. Abdomen was soft. Bowel sounds in the left lower abdomen were lively. The subject showed no signs of hepatosplenomegaly or palpable pathologic resistances. Cranial asymmetry with flat area was found at the right occiput. At the back petechiae which were first experienced about two days ago and have not increased in numbers since that time. Two hemangiomas of about 2 mm were found at the right frontal axilla. Joints were normal. Pupils were normal. Tympanic membranes were normal and reflective. Mouth and throat were normal. Lymph nodes not palpable enlarged. Heart sounds clear and rhythmic. No pathologic heart murmur. Lungs both sides well ventilated, vesicular rales, no rhonchi. Genitals male and normal descended. No signs of meningism. No fever. The subject was hospitalised for possible intussusception of intestine most likely post vaccination with ROTARIX. Intussusception of intestine was confirmed by abdominal ultrasonography, performed on 13 May 2012, which showed characteristic cocarde structure in the right lower abdomen and lively peristalsis. Treatment included hydrostatic disinvagination without showing pathologic results. Oral nutrition build-up was performed without complications. Stool frequency and stool consistency were normal. Follow-up abdominal ultrasonography, performed on 14 May 2012, did not show any longer pathologic cocarde structure or intussusception, but still showed thickening of ileum at the terminal end and distinct mesenteric lymphadenopathy. On 15 May 2012 the subject was discharged in good general condition post normal examinations at discharge for ambulatory follow-up. After about four days, on 15 May 2012, all events were resolved. The vaccination course with ROTARIX was discontinued. The reporting physician considered that intussusception of intestine was possibly related to vaccination with ROTARIX. The reporting physician also provided the answers to a GSK targeted questionnaire for intussusception post vaccination with ROTARIX: The subject was diagnosed with intussusception. Symptoms started on 13 May 2012 and resolved on 14 May 2012. Plain abdominal radiograph was not performed. Air or liquid contrast enema was not performed. Abdominal examinations showed non-specific abnormalities. Abdominal ultrasound showed a visible intussusceptum or soft tissue mass. An intra-abdominal mass with specific characteristic features (target sign or doughnut sign on transverse section and a pseudo-kidney or sandwich sign on longitudinal section) was demonstrated and proven to be reduced by hydrostatic enema on post-reduction ultrasound. Abdominal computerized tomogram scan was not performed. Surgery was not performed. Family history did not include intussusception or bowel abnormalities. the subject''s medical history did not include previous intra-abdominal surgery, congenital intestinal malformation, intestinal polyps, Meckel''s diverticulum, intestinal vascular malformations, cystic fibrosis, Hirschsprung''s disease or other gastrointestinal malformation and dysfunction. No information was provided concerning intussusception. The event did not resolve spontaneously. The event resolved by liquid contrast or hydrostatic water or air enema. No information was provided concerning surgical reduction. No information was provided concerning surgical resection. No information was provided concerning radiological procedure. No information was provided concerning surgery. The subject survived. No further information will be available.


VAERS ID: 459678 (history)  
Form: Version 1.0  
Age: 0.27  
Sex: Female  
Location: Foreign  
Vaccinated:2012-03-27
Onset:2012-04-22
   Days after vaccination:26
Submitted: 2012-07-19
   Days after onset:88
Entered: 2012-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA414AA / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal abscess, Crying, Echography normal, Haematochezia, Intussusception, Mood altered, Retroperitoneal mass, Rotavirus test negative, Soft tissue mass, Stool analysis normal, Surgery, Ultrasound abdomen abnormal, X-ray normal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Gastrointestinal obstruction (narrow), Gastrointestinal perforation (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Ischaemic colitis (broad), Depression (excl suicide and self injury) (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Echography, 23Apr2012, abdominal: no ab; Echography, 24Apr2012, abdominal: no ab; Stool analysis, 22Apr2012, No rotavirus was
CDC Split Type: B0812000A

Write-up: This case was reported by a physician and described the occurrence of invagination of intestine in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 27 March 2012, the subject received unspecified dose of ROTARIX (1.5 ml, oral). On 22 April 2012, 26 days after vaccination with ROTARIX, the subject experienced invagination of intestine. The subject visited the department of pediatrics at a hospital. Within that day, reduction was performed. The subject was admitted to the hospital and observed just in case. No rotavirus was detected in the faeces. On 23 April 2012, the subject was discharged from the hospital in the morning. In the evening on the same day, invagination of intestine occurred again. Within that day, reduction was performed. The subject was admitted to the hospital and observed just in case. On 24 April 2012, the event was resolved and the subject was discharged from the hospital in the morning. The physician considered the event was related to vaccination with ROTARIX. Although time had passed since the vaccination, it was difficult to assume that the event was unrelated to ROTARIX. Follow-up information received on 9 July 2012: Subject details were added. The subject had no family history of intussusception or intestinal abnormality. The subject had not undergone a laparoscopic surgery in the past. Subject''s medical history did not include congenital intestinal malformation, intestinal polyp, Meckel''s diverticulum, intestinal vascular malformation, cystic fibrosis, Hirschsprung''s disease, other gastrointestinal malformation and dysfunction or intussusception. Concurrent vaccinations included PREVENAR and ACTHIB given on 27 March 2012. On 22 April 2012, 26 days after vaccination with ROTARIX, the subject was in a bad mood from around noon, and at 16:00, bloody stools were noticed. On 22 April 2012 at 18:46, the subject visited the emergency department of the reporting hospital. Non-invasive air reduction was performed with a diagnosis of invagination of intestine, and she was hospitalized. On 23 April 2012 at 09:00, no abnormality was shown by abdominal echography and the subject had no symptoms. On 23 April 2012 at 14:00, the subject was discharged from the hospital. On 23 April 2012, past 18:00, the subject cried out every 5 minutes. On 23 April 2012 at 19:29, the subject visited the emergency department of the reporting hospital. Non-invasive air reduction was performed with a diagnosis of recurrent invagination of intestine and she was hospitalized. On 24 April 2012 at 09:00, no abnormality was shown by abdominal echography and she had no symptoms. On 24 April 2012 at 16:30, the subject was discharged from the hospital. At an unspecified time after vaccination with ROTARIX, the subject also experienced intra abdominal abscess. Visible intussusception or soft tissue mass on plain abdominal X-ray was not confirmed. Niveau and distended intestinal loops on plain abdominal X-ray was not confirmed. Intussusception findings with enema of air or contrast medium was confirmed. Nonspecific abnormalities on plain abdominal X-ray was not confirmed. Visible intussusception or soft tissue mass on abdominal ultrasound was confirmed. Presence of intraperitoneal mass with specific features was observed. Visible intussusception or soft tissue mass on abdominal CT scanning was not conducted. The symptoms did not disappear spontaneously. Abnormality disappeared with enema of contrast media/ fluid pressure/air. Correction surgery was not required (but not performed). Ablative surgery was not required. Complication with X-ray procedure was not reported. Complication with operational procedure was not reported. The subject survived. The causal relationship between Rotavirus vaccination and invagination of intestine could not be determined clearly ; however, it was the most suspected factor considering the recurrence of invagination of intestine.


VAERS ID: 459950 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Male  
Location: Foreign  
Vaccinated:2012-05-08
Onset:0000-00-00
Submitted: 2012-07-23
Entered: 2012-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA261CC / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Blood calcium decreased, Blood chloride normal, Blood lactate dehydrogenase increased, Blood potassium normal, Blood sodium normal, C-reactive protein normal, Crying, Dysphagia, Flatulence, Fluid intake reduced, Gastrointestinal sounds abnormal, Haemoglobin normal, Infantile spitting up, Intussusception, Lymphocyte percentage increased, Monocyte percentage, PCO2 increased, Pallor, Restlessness, Therapeutic procedure, Ultrasound abdomen abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Akathisia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Respiratory failure (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? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood calcium, 19May2012, 1.42mmol/l; Blood chloride, 19May2012, 107mmol/l; Blood potassium, 19May2012, normal; Blood sodium, 19May2012, normal; C-reactive protein, 19May2012, normal; Hemoglobin, 19May2012, 10.8g/dl; Lactate dehydrogenase, 19May2012, 325U/l; Lymphocyte percentage, 19May2012, 67.8%; Monocyte percentage, 19May2012, 6.0%; PCO2, 19May2012, 31.1mmHg; PO2, 19May2012, 59.4mmHg; Ultrasound scan, May2012, follow-up: normal; Ultrasound scan, 19May2012, pathologic
CDC Split Type: D0076074A

Write-up: This case was reported by a foreign regulatory authority (# DE-PEI-PEI2012019050) and described the occurrence of ileocolic intussusception in an 11-week-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Medical history was not provided. The subject did not experience any previous adverse events post vaccination. On 08 May 2012 the subject received the first dose of ROTARIX (1.5 ml, oral). Approximately 10 to 11 days post vaccination with ROTARIX, between 18 May 2012 and 19 May 2012, the subject experienced intussusception. The subject was hospitalised for an unknown period of time. Diagnosis of intussusception was confirmed by ultrasonography. Information on treatment was not provided. After about three days, on or around 21 May 2012, the event was resolved. The vaccination course with ROTARIX was discontinued. Follow-up information including a preliminary hospital report was received on 17 July 2012 from the foreign regulatory authority. The subject was born as a mature newborn (term birth) with a birth weight of 3450 gram and an Apgar score of 10/10. Up to now there had been no preceding medical conditions. The subject has no known risk factors for intussusception. The subject has no siblings. Less than 10 days post vaccination with ROTARIX, prior to 18 May 2012, the subject experienced increased restlessness, increased crying and reduced fluid intake for several days. The subject kept spitting out the offered milk and refused swallowing. The subject did not experience any fever. On 19 May 2012 the subject was hospitalised for three days for intussusception. On admission to hospital the subject was intermittently crying and persistently crying during abdominal palpitation. Bowel sounds were moderately increased. Skin coloration was pale rosy. Fontanel was within normal limits and soft. Pharyngeal and oral mucosal membranes were bland. Lungs and heart examinations were normal. Abdominal ultrasonography on admission, on 19 May 2012, showed distinct ileocolic intussusception besides air. The subject was treated with hydrostatic disinvagination under mild sedation with midazolam without complications. Additionally the subject received a single dose of CLAFORAN. During the following two days of monitoring in the hospital the subject was always in good general condition and showed no signs of recurrence of intussusception. Additionally, abdominal follow-up ultrasonography confirmed the success of treatment and showed no increased lymph nodes. On 21 May 2012 the subject was discharged from hospital in good general condition for follow-up. The foreign regulatory authority has requested further information. No further information will be available.


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