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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: 332811 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2008-10-02
Onset:2008-10-05
   Days after vaccination:3
Submitted: 2008-11-19
   Days after onset:45
Entered: 2008-11-19
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, Blood creatinine normal, Blood glucose normal, Blood urea increased, Flatulence, Gastrointestinal sounds abnormal, Haematocrit decreased, Haemoglobin normal, Ileal perforation, Intestinal anastomosis, Intestinal obstruction, Intestinal resection, Intussusception, Irritability, Lymphadenitis, Lymphocyte percentage, Neutrophil percentage, Platelet count normal, Pyrexia, Surgery, Vomiting, White blood cell count, X-ray abnormal
SMQs:, Acute renal failure (broad), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (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 perforation (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), 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, 21 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 06Oct2008, see text; Blood glucose, 07Oct2008, 99mg/dl; Creatinine, 07Oct2008, 0.31mg/dl; Hematocrit, 07Oct2008, 34.9%; Hemoglobin, 07Oct2008, 11.9g/dl; Leukocyte count NOS, 07Oct2008, 13000mm3; Lymphocytes, 07Oct2008, 27.8%; Neutrophils, 07Oct2008, 59.20%; Platelet count, 07Oct2008, 302000mm3; urea, 07Oct2008, 46mg/dl
CDC Split Type: B0546365A

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). On 2 October 2008, 3 days after vaccination with ROTARIX, the subject presented vomiting, irritability, abdominal distension and fever. The subject received ambulatory treatment with co-trimoxazole , acetaminophen and metaclopramide without improvement. On 06 October 2008 the subject was hospitalized. Subject''s physical examination showed abdominal distension, absence of bowel sounds and tympanites. The x-ray showed dilated loops, edema between loop and loop and bounden loop. The diagnosis made by clinical feature and abdominal x-ray was intestinal obstruction and intussusception. On 08 October 2008 the subject underwent a surgery in which ileocecocolic intussusception with 5cm length perforation in ileum and mesenteric adenitis was found. Reduction by taxis and intestinal resection of 8 cm length in terminal ileum with anastomosis was performed. The subject''s evolution was bad. Therefore on 15 October 2008 the subject underwent a 2nd surgery in which 50% anastomosis dehiscence and 8mm of new intestinal perforation was found. A new resection of 5 cm in ileum and new anastomosis was performed. The subject showed good evolution. On 27 October 2008 the subject was discharged in good conditions. The subject was treated with (Acetaminophen), Ranitidine, amikacin, metronidazole, midazolam, sodium bicarbonate and cefotaxime. The physician considered the events were possibly related to vaccination with ROTARIX.


VAERS ID: 332888 (history)  
Form: Version 1.0  
Age: 0.5  
Gender: Female  
Location: Foreign  
Vaccinated:2008-10-13
Onset:2008-10-16
   Days after vaccination:3
Submitted: 2008-11-20
   Days after onset:35
Entered: 2008-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Haematochezia, Haemorrhage, Intussusception, Pyrexia, Surgery
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0546499A

Write-up: This case was reported by a physician and described the occurrence of invagination of intestine in a 7-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous vaccination included ROTARIX (GlaxoSmithKline, oral) given on an unspecified date. On 13 October 2008, the subject received 2nd dose of ROTARIX (oral). Lot number not provided. At an unspecified time after vaccination with ROTARIX, the subject experienced invagination of intestine. The subject was hospitalised and had a surgery. At the time of reporting the outcome of the event was unspecified. Follow up information received on 17 November 2008 from the physician: On 16 October 2008, 3 days after vaccination with ROTARIX, the subject experienced fever, bleeding and bloody stools. The subject was hospitalised. Invagination of intestine was diagnosed and resolved by surgery on 20 October 2008. The physician considered the events were life threatening and clinically significant (or requiring intervention). On 20 October 2008, the events were resolved.


VAERS ID: 332984 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:2008-09-29
Onset:2008-10-04
   Days after vaccination:5
Submitted: 2008-11-21
   Days after onset:48
Entered: 2008-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Anorexia, Crying, Fatigue, Haematochezia, Intussusception, Lethargy, Ultrasound scan abnormal, X-ray abnormal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ischaemic colitis (broad), Depression (excl suicide and self injury) (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? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, see text; Diagnostic ultrasound, see text
CDC Split Type: B0542225A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 29 September 2008 the subject received unspecified dose of ROTARIX (oral) lot number not provided. On 4 October 2008, 5 days after vaccination with ROTARIX, the subject experienced intussusception which was resolved by single contrast enema. The physician considered the event was clinically significant (or requiring intervention). Relevant test results included abnormal ultrasound. On 4 October 2008, the event was resolved. The physician considered the event was possibly related to vaccination with ROTARIX. Follow up received on 20 November 2008: The physician that reported intussusception was not the physician who vaccinated the child. The reporter refused to give the name of the pediatrician who followed up the baby since birth. Then further details about vaccination could not be obtained. Five days post vaccination the subject developed lethargy, fatigue, loss of appetite, intractable crying and bloody stool. Relevant test included abdominal x-ray which demonstrated invagination of the intestine by air/liquid contrast enema. Abdominal ultrasound showed visible intussusception or soft tissue mass and demonstration of an intra-abdominal mass with specific characteristic features that is proven to be reduced by hydrostatic enema on post-reduction ultrasound.


VAERS ID: 333142 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-08-13
Onset:2008-09-01
   Days after vaccination:19
Submitted: 2008-11-24
   Days after onset:84
Entered: 2008-11-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal mass, Abdominal pain, Barium enema abnormal, Blood creatine decreased, Blood glucose increased, Blood urea increased, Diet refusal, Gastrointestinal sounds abnormal, Haematochezia, Haematocrit normal, Haemoglobin normal, Inappropriate schedule of drug administration, Intestinal mass, Intussusception, Irritability, Neutrophil percentage increased, Pain, Pallor, Palpitations, Platelet count increased, Pyrexia, Rectal haemorrhage, Surgery, Vomiting, White blood cell count increased
SMQs:, Acute renal failure (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (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), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), 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, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Barium enema, 01Sep2008, See text; Blood glucose, 01Sep2008, 114mg/dL; Creatinine, 01Sep2008, 0.4mg/dL; Hematocrit, 01Sep2008, 35.9%; Hemoglobin, 01Sep2008, 12g/L; Neutrophil percentage, 01Sep2008, 71.3%; Platelet count, 01Sep2008, 582000/mm3; Urea, 01Sep2008, 21mg/dL; White blood cell count, 01Sep2008, 19000/mm3
CDC Split Type: B0547121A

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 male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history or allergy. Concurrent vaccination included pneumococcal vaccine (manufacturer unspecified; intramuscular; unknown injection site) given on 13 August 2008. On 13 August 2008, the subject received the 1st dose of ROTARIX (oral, lot number not provided). On 1 September 2008, 19 days after vaccination with ROTARIX, the subject experienced irritability, oral unacceptance, gastrobiliary vomiting (3), fever and bloody stools (5). The subject received ambulatory treatment with "Toprom", FLORATIL and PEPTOBISMOL without improvement. The subject was hospitalised. Physical exam with pallor, abdominal mass in left flank, pain to the palpation, incremented bowel sounds, Dance sign positive. Rectal mass and fresh blood in rectal tact. Laboratory tests were performed and showed the following: Glucose: 114 mg/dL; Urea: 21mg/dL; Creatinine: 0.4 mg/dL; Leucocytes: 19000/mm3; Hematocrit: 35.9%; Hemoglobin: 12 g/dL; Platelets: 582000/mm3; Neutrophils: 71.3%. Barium Enema was performed and showed inferior occlusion probably in the descending colon and sigmoid. Diagnosis of intestinal intussusception was made. 01 September 2008, surgery was performed: Ileocecocolic intussusception was found and reduced by taxis without complications. The subject was treated with BISMUTH and RANITIDINE. On 7 September 2008, the subject was discharged in good clinical conditions. On 7 September 2008, the events were resolved. The physician considered the events were possibly related to vaccination with ROTARIX.


VAERS ID: 333502 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2007-11-15
Onset:2008-06-15
   Days after vaccination:213
Submitted: 2008-12-01
   Days after onset:169
Entered: 2008-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal mass, Anorexia, Decreased activity, Dehydration, Diarrhoea, Intussusception, Irritability, Pallor, Pyrexia, Surgery, Ultrasound abdomen abnormal, X-ray abnormal
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (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, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 17Jun2008, Abnormal; Ultrasound abdomen, 17Jun2008, Abnormal
CDC Split Type: B0548192A

Write-up: This case was reported by a physician and described the occurrence of ileocecocolic intussusception in a 11-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical or family history. Previous and/or concurrent vaccination included BACILLUS CALMETTE-GUERIN vaccine (non-gsk); manufacturer unspecified; intradermal; given on 9 July 2007; combined DTaP-IPV-HIB; manufacturer unspecified; intramuscular; given on 17 September 2007, 15 November 2007 and 17 January 2008; Hep B; manufacturer unspecified; intramuscular; given on 9 July 2007, 17 September 2007 and 17 January 2008; influenza virus vaccine; manufacturer unspecified; intramuscular; given on 17 January 2008 and 12 May 2008; live attenuated ROTARIX; GlaxoSmithKline; oral given on 17 September 2007; live attenuated oral poliomyelitis vaccine; GlaxoSmithKline; oral given on 22 May 2008; pneumococcal vaccine, unspecified; manufacturer unspecified; intramuscular; given on 17 September 2007 and 15 November 2007. On 15 November 2007, the subject received 2nd dose of ROTARIX (oral), lot number not provided. On 15 June 2008, 7 months after vaccination with ROTARIX, the subject experienced diarrhea with hyporexia, irritability and fever, leading to hospitalisation. Physical examination revealed pallor, dehydration, hypoactivity and abdominal mass (Morcilla''s sign). The subject was hospitalised for 5 days and the physician considered the events were life threatening and clinically significant (or requiring intervention). On 17 June 2008, abdomen X-ray and ultrasound performed revealed a visible intussusceptum as well as fluids levels and dilated bowel loops. Surgery was performed and an ileocecocolic intussusception without vascular complication was found and reduced by taxis without complication. No resection was done. On 19 June 2008, the events were resolved and the subject was discharged from hospital in good clinical condition. The physician considered the events were possibly related to vaccination with ROTARIX.


VAERS ID: 333503 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-04-22
Onset:2008-06-22
   Days after vaccination:61
Submitted: 2008-12-01
   Days after onset:162
Entered: 2008-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Anorexia, Inappropriate schedule of drug administration, Intussusception, Irritability
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Medication errors (narrow), Hypoglycaemia (broad)

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:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0548197A

Write-up: This case was reported by a physician and described the occurrence of invagination of intestine in a 6-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical or family history. Previous and/or concurrent vaccination included bacillus calmette-guerin vaccine (manufacturer unspecified, intradermal) given on 24 December 2007; DTaP-IPV-HIB (manufacturer unspecified, intramuscular) given on 22 February 2008 and 22 April 2008; Hep B(manufacturer unspecified, intramuscular) given on 22 February 2008 and 22 April 2008; ROTARIX (GlaxoSmithKline, oral) given on 22 February 2008; pneumococcal vaccine (manufacturer unspecified) given on 22 February 2008 and 22 April 2008. On 22 April 2008, the subject received 2nd dose of ROTARIX (oral). Lot number not provided. on 22 June 2008, 61 days after vaccination with ROTARIX, the subject started with abdominal pain, irritability and hyporexia. The subject was hospitalized and invagination of intestine was diagnosed by clinical data. No x-ray or ultrasound was performed. Intestinal invagination type ileocecocolic without vascular complications was found and resolved by taxis without complications. The physician considered the events were life threatening and clinically significant (or requiring intervention). On 24 June 2008, the events were resolved and the subject was discharged in good conditions. The physician considered the events were possibly related to vaccination with ROTARIX. No further information expected, the case has been closed.


VAERS ID: 333514 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Foreign  
Vaccinated:2008-11-08
Onset:2008-11-16
   Days after vaccination:8
Submitted: 2008-12-01
   Days after onset:15
Entered: 2008-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FA614A / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal pain, Barium enema, Haematochezia, Intussusception, Surgery, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, Nov2008, Abnormal
CDC Split Type: B0547195A

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). Previous and/or concurrent vaccination included ROTARIX; GlaxoSmithKline given on 27 September 2008. On 8 November 2008, the subject received 2nd dose of ROTARIX (oral). On 16 November 2008, 8 days after vaccination with ROTARIX, the subject experienced bloody stools and abdominal pain, leading to hospitalisation, intussusception. The physician considered the events were clinically significant (or requiring intervention). The abdomen X-ray revealed an intussusception. On 17 November 2008, the subject was unsuccessfully treated with barium salt. The same day, surgery was performed. At the time of reporting the subject was still hospitalised and the events are improving. The physician considered the events were possibly related to vaccination with ROTARIX.


VAERS ID: 333536 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Foreign  
Vaccinated:2008-06-11
Onset:2008-10-06
   Days after vaccination:117
Submitted: 2008-12-01
   Days after onset:56
Entered: 2008-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Dehydration, Diarrhoea, Gastrointestinal sounds abnormal, Haematochezia, Intussusception, Irritability, Laparotomy, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (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), Noninfectious diarrhoea (narrow), 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, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Healthy Baby
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0547633A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent medical conditions included healthy baby. On 11 June 2008 the subject received 1st dose of ROTARIX (oral). On 6 October 2008, more than 3 months after vaccination with ROTARIX, the subject experienced abdominal pain, vomiting, diarrhea and fever. The subject was admitted to the emergency room. Physical examination showed irritability, bloody stools, dehydration and bowel sounds decreased. The subject was hospitalized. Clinical diagnostic of intussusception was suspected and corroborated by laparotomy. Intussusception was resolved by taxis without complications. On 09 October 2008 the subject was discharged in good clinical conditions. The reporter considered the events were clinically significant or intervention required. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 333541 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2008-09-23
Onset:2008-11-12
   Days after vaccination:50
Submitted: 2008-12-01
   Days after onset:19
Entered: 2008-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal mass, Abdominal pain, Anorexia, Asthenia, Dehydration, Enema administration, Haematochezia, Intussusception, Irritability, Mucous stools, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (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, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 13Nov2008, see text
CDC Split Type: B0547954A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 5-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous vaccination included ROTARIX; GlaxoSmithKline; oral given on 24 July 2008. On 23 September 2008 the subject received 2nd dose of ROTARIX (oral). On 12 November 2008, 50 days after vaccination with ROTARIX, the subject experienced hyporexia, asthenia, adynamia, irritability, dehydration, abdominal pain, gastrobiliar vomiting and a bloody stool. The subject received ambulatory treatment Butilhioscine, Dimeticone, racecadotril, Diphenidol and electrolytes without improvement. On 13 November 2008 the subject was hospitalized. Physical examination showed abdominal pain, abdominal distension, abdominal mass in transverse colon, positive dance sign and rectal tact with spontaneous current jelly stools. Abdominal x-ray showed bad air distribution, dilated loop in left flank and right ileac fossa and distal lack of air. Diagnosis of intussusception was made and it was resolved by pneumonenema. On 18 November 2008 the subject was discharged in good clinical conditions. The subject was treated with omeprazole, Metamizole, Amikacine, metronidazole and enema. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 333667 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Male  
Location: Foreign  
Vaccinated:2008-06-24
Onset:2008-11-21
   Days after vaccination:150
Submitted: 2008-12-02
   Days after onset:11
Entered: 2008-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal pain, Barium enema abnormal, Intussusception, Irritability, Laparotomy, Ultrasound abdomen abnormal, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (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: Abdominal X-ray, 21Nov2008, IS; Ultrasound abdomen, 21Nov2008, IS
CDC Split Type: B0547992A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of ileocolic intussusception in a 9-month-old male subject who was vaccinated with ROTARIX, (GlaxoSmithKline). Previous and/or concurrent vaccination included ROTARIX; GlaxoSmithKline; oral given on 15 April 2008. On 24 June 2008 the subject received 2nd dose of ROTARIX (oral). On 21 November 2008, 150 days after vaccination with ROTARIX, the subject experienced irritability, abdominal pain and biliary vomiting. Abdominal x-ray showed a probable intussusception. Abdominal ultrasound and barium enema confirmed the diagnosis without reducing it. The same day the subject was admitted to the emergency room without clinical signs of intussusception. At physical examination only bowel was study. Laparotomy was done. ileocolic intussusception was confirmed and it was resolved by taxis without complications. On 23 November 2008 the subject was discharged fully recovered and in good clinical conditions. The subject was hospitalized for 3 days and the physician considered the events were clinically significant (or requiring intervention). The subject was treated with cefotaxime, Metamizole, midazolam, Ranitidine. The physician considered the events were possibly related to vaccination with ROTARIX.


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