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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: 314130 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2008-01-15
Onset:2008-04-19
   Days after vaccination:95
Submitted: 2008-05-29
   Days after onset:40
Entered: 2008-05-29
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, Anorexia, Barium enema abnormal, Decreased appetite, Diarrhoea, Flatulence, Gastrointestinal sounds abnormal, Haematochezia, Intestinal functional disorder, Intussusception, Mass, Mucous stools, Nausea, Pallor, Vomiting, White blood cell count decreased, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 20Apr2008, See text; Barium enema, 20Apr2008, See text; White blood cell count, 20Apr2008, 4200/mm3, 5000, 1500
CDC Split Type: B0521383A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 7-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history or allergy. Previous vaccinations included combined diphtheria, tetanus, whole cell pertussis, hepatitis B and Haemophilus type b vaccine (manufacturer unspecified; intramuscular; unknown) given on 19 March 2008; influenza virus vaccine (manufacturer unspecified; intramuscular; unknown) given on 19 March 2008; live attenuated oral poliomyelitis vaccine (manufacturer unspecified; oral) given on 19 March 2008 and live attenuated human rotavirus vaccine (GlaxoSmithKline; oral) given on 12 November 2007. On 15 January 2008, the subject received the 2nd dose of ROTARIX (oral, lot number not provided). On 19 April 2008, 95 days after vaccination with the 2nd dose of ROTARIX, the subject experienced abdominal pain and liquid stools. Thereafter she showed hyporexia, nausea, vomiting and current jelly stools. On 20 April 2008, she was admitted on ER. Physical exam reported abdominal pain, pallor, palpable mass, Dance sign, absent peristalsis and rectal tract with expulsion of fresh bloody stools. Laboratory tests were performed on 20 April 2008 and showed the following: Leucocytes: 4200/mm3 (normal range: 5000-15000). Abdominal X-ray showed air-fluid levels. Barium enema was done; fluoroscopy control showed pass contrast medium through ileocecal valve to distal ileum; therefore ileocecolic intussusception was resolved (by exit). The subject was treated with AMPICILLIN, AMIKACINE, metronidazole and RANITIDINE. The subject had a good clinical evolution. The subject was discharged on 24 April 2008 with frank recuperation. On 24 April 2008, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 314406 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Foreign  
Vaccinated:2007-10-08
Onset:2008-03-09
   Days after vaccination:153
Submitted: 2008-05-30
   Days after onset:81
Entered: 2008-05-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 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
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal pain, Appendicectomy, Dehydration, Diarrhoea, Gastrointestinal hypomotility, Haematochezia, Hypovolaemia, Intensive care, Intussusception, Irritability, Surgery, Vomiting, Wheezing, X-ray abnormal
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (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), Hostility/aggression (broad), Ischaemic colitis (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), 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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 11Mar2005, see textunit
CDC Split Type: B0522122A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 7-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included DTaP-IPV-HIB (manufacturer unspecified, intramuscular) given on 8 October 2007 and 13 February 2008; hepatitis B vaccine recombinant (manufacturer unspecified, intramuscular) given on 8 October 2007 and 13 February 2008; influenza virus vaccine (manufacturer unspecified, intramuscular) given on 7 August 2007 and 7 February 2008; pneumococcal vaccine, unspecified (manufacturer unspecified, intramuscular) given on 6 November 2007; tuberculosis vaccine (manufacturer unspecified, intradermal) given on 7 August 2007. On 8 October 2007 the subject received 1st dose of ROTARIX (oral). On 9 March 2008, 5 months after vaccination with ROTARIX, the subject experienced irritability, gastric vomiting, 9 x), fetid liquid stools. On 10 March 2008, the subject presented bloody stools, abdominal distension and continued vomiting. The subject went to the emergency room presenting dehydration, irritability, a few wheezing, decreased peristalsis and abdominal pain without palpable mass. Relevant test performed on 11 March 2008 included abdominal x-ray with air fluid levels which showed very dilated intestinal loops. The same day the subject underwent a surgery where it was found ileocecal intussusception and it was reduced by taxis. The subject also had an appendectomy. During surgery the subject had hypovolemia and he was sent to pediatric intensive care unit for hemodinamic monitoring. He presented ileo reflux improvement for 36 hours. The physician considered the events were clinically significant (or requiring intervention). The subject was treated with AMPICILLIN, pain medication and gastric protection. On 18 March 2008, the subject was discharged in good clinical conditions. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 314408 (history)  
Form: Version 1.0  
Age: 5.0  
Gender: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2008-05-01
Submitted: 2008-05-30
   Days after onset:29
Entered: 2008-05-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, Intussusception
SMQs:, Gastrointestinal obstruction (narrow), Medication errors (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0522166A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 5-year-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date, the subject received 2nd dose of ROTARIX (oral), lot number not provided. In May 2008, at an unspecified time after vaccination with ROTARIX, the subject experienced intussusception. The subject was hospitalised. At the time of reporting the event was unresolved.


VAERS ID: 314409 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2008-04-30
Onset:2008-05-05
   Days after vaccination:5
Submitted: 2008-05-30
   Days after onset:25
Entered: 2008-05-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Enema administration, Intussusception, Malaise, Ultrasound abdomen abnormal
SMQs:, Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (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: Ultrasound abdomen, 06May2008, ISunit
CDC Split Type: B0522202A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was in her weight and size according to her age and in good health. The subject''s did not have any medical history of intussusception. She had a twin sister who received ROTARIX the same day without developing any adverse event. On 30 April 2008 the subject received 1st dose of ROTARIX (oral) lot number not provided. On 5 May 2008, 5 days after vaccination with ROTARIX, the subject started to feeling unwell. On 06 May 2008 the subject was brought to hospital and intussusception was diagnosed after abdominal ultrasound. The subject did not have fever or diarrhea or bloody stools. The subject was hospitalised for 5 days and discharged completely recovered. The subject was treated with enema. The physician considered the events were almost certainly related to vaccination with ROTARIX. Further information was not expected and therefore this case has been closed.


VAERS ID: 314412 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2008-02-08
Onset:2008-02-13
   Days after vaccination:5
Submitted: 2008-05-30
   Days after onset:106
Entered: 2008-05-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Intussusception
SMQs:, Gastrointestinal obstruction (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, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: D0057465A

Write-up: This three-month-old female subject was enrolled in a epidemiological study to gather epidemiological back-ground data on the incidence of intussusception. The subject received oral ROTARIX on 08 February 2008. On 13 February 2008, five days after vaccination with ROTARIX, this three-month-old subject developed intussusception. The subject was hospitalised for 2 days. The disease took an uncomplicated course. The event resolved on 14 February 2008 and the subject was discharged after successful reposition. Investigator causality was unknown at the time of reporting. Follow-up information has been requested.


VAERS ID: 315017 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2008-01-08
Onset:2008-03-14
   Days after vaccination:66
Submitted: 2008-06-04
   Days after onset:82
Entered: 2008-06-04
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, Decreased activity, Dehydration, Faecal vomiting, Flatulence, Gastrointestinal hypomotility, Gastrointestinal necrosis, Haematochezia, Intestinal anastomosis, Intestinal resection, Intussusception, Pyrexia, Surgery, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (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? No
ER or Doctor Visit? No
Hospitalized? Yes, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 19Mar2008, Abnormalunit
CDC Split Type: B0522325A

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 under no other medication and had no relevant medical history nor allergy. Previous and/or concurrent vaccination included ROTARIX; GlaxoSmithKline; oral given on 8 November 2007. On 8 January 2008, the subject received 2nd dose of ROTARIX (oral), lot number not provided. On 14 March 2008, 66 days after vaccination with ROTARIX, the subject experienced vomiting and fever. On 16 March 2008, she experienced bloody stools. On 19 March 2008, the subject experienced abdominal distension without peristalsis and 2 vomitings like feces, leading to hospitalisation at emergency ward. At physical examination, the subject was dehydrated, hypoactive with a distended abdomen. Abdominal X-ray showed air fluid levels and lack of air in rectum. The subject was transferred to another hospital where after confirmation of previous examination results, surgery was performed and ileocecocolic intussusception to descendent colon and ileocecal valve with proximal ascendant colon necrosis were found. Taxis was performed in 80 % of intussusceptoin as well as 15 cm of bowel resection end to end anastomosis. The subject was hospitalised for 14 days. The subject was treated with ranitidine, cefotaxime, metamizole, ampicilline, amikacin, metronadizole and dicloxacillin. On 1 April 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: 315018 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:2008-02-25
Onset:2008-04-22
   Days after vaccination:57
Submitted: 2008-06-04
   Days after onset:43
Entered: 2008-06-04
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, Barium enema abnormal, Enema administration, Flatulence, Gastrointestinal hypomotility, Haematochezia, Haematocrit normal, Haemoglobin normal, Intestinal mass, Intestinal obstruction, Intussusception, Lymphocyte percentage, Neutrophil percentage increased, Platelet count increased, Pyrexia, Vomiting, White blood cell count normal, 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), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), 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, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 23Apr2008, Abnormalunit; Barium enema, 23Apr2008, intussusceptionunit; Hematocrit, 23Apr2008, 35%; Hemoglobin, 23Apr2008, 12g/dl; Lymphocytes, 23Apr2008, 26%; Neutrophils, 23Apr2008, 73%; Platelet count, 23Apr2008, 543000/mm3; White blood cells, 23Apr2008, 6500/mm3
CDC Split Type: B0522112A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was under no other medication and had no relevant medical history nor allergy. She was healthy at the time of vaccination. Previous and/or concurrent vaccination included pneumococcal vaccine, unspecified; manufacturer unspecified; intramuscular; given on 2 April 2008. On 25 February 2008, the subject received 1st dose of ROTARIX (oral), lot number not provided. On 22 April 2008, 57 days after vaccination with ROTARIX, the subject experienced five times vomitings and fever. On 23 April 2008, the subject was hospitalised. The physical examination revealed a distended painful abdomen without peristalsis and palpable intestinal loop. The rectal tact revealed a mass and showed bloody stool on the explorer finger. The X-ray abdomen showed air-fluid levels and distended intestinal loop of superior left side. The diagnosis of intestinal obstruction by intussusception was made based on clinical data and abdomen X-ray. The fluoroscopic control revealed the ileocolic intussusception. The colon barited enema was successfully performed. The subject was hospitalised for 4 days. The subject was treated with paracetamol. The clinical evolution was favourable. On 26 April 2008, the events were resolved and the subject was discharged from hospital. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 315141 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:2008-05-07
Onset:2008-05-26
   Days after vaccination:19
Submitted: 2008-06-05
   Days after onset:10
Entered: 2008-06-05
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 pain, Intussusception, Rectal haemorrhage, 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? Yes
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, 26May2008, Abnormalunit
CDC Split Type: B0522850A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 7 May 2008, the subject received 1st dose of ROTARIX (oral), lot number not provided. On 26 May 2008, 19 days after vaccination with ROTARIX, the subject experienced rectal bleeding and abdominal pain. The diagnosis of intussusception was made based on symptoms evaluation and abdomen X-ray. The subject was hospitalised and the physician considered the events were life threatening and clinically significant (or requiring intervention).Surgery was performed on 26 May 2008. At the time of reporting the events were improved. The subject was still hospitalised and oral feeding was began.


VAERS ID: 315148 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-05-23
Onset:2008-05-27
   Days after vaccination:4
Submitted: 2008-06-05
   Days after onset:9
Entered: 2008-06-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA564A / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Crying, Depressed mood, Enema administration, Intussusception, Ultrasound abdomen abnormal
SMQs:, Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Depression (excl suicide and self injury) (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, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: ultrasound abdomen, 27May2008, intussusceptunit
CDC Split Type: B0523095A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). No medical history of intussusception was reported. On 23 May 2008, the subject received 1st dose of ROTARIX (oral) as well as the vaccines corresponding for 4 months of age. His twin brother was also vaccinated the same day with ROTARIX. He experienced no adverse event. On 27 May 2008, 4 days after vaccination with ROTARIX, the subject experienced crying crisis and low mood. He didn''t experience diarrhea or bloody stools. The subject was brought to hospital and abdominal ultrasound revealed an intussusception which was resolved by air enema. The subject was hospitalised for 2 days. At the time of reporting the events were resolved. The subject was discharged from hospital in good condition. The physician did not think the intussusception was related to vaccination with ROTARIX but she could not rule out completely. Further information is not expected. This case has therefore been closed.


VAERS ID: 315150 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2008-02-08
Onset:2008-02-12
   Days after vaccination:4
Submitted: 2008-06-05
   Days after onset:113
Entered: 2008-06-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA385A / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Base excess negative, Blood bicarbonate normal, Blood electrolytes normal, Blood glucose increased, Blood lactate dehydrogenase normal, Blood pH normal, Body temperature increased, C-reactive protein normal, Enema administration, Gamma-glutamyltransferase normal, Haemoglobin normal, Intussusception, Mean cell haemoglobin normal, Mean cell volume normal, Oedema, PCO2 normal, PO2 increased, Platelet count normal, Prothrombin time, Prothrombin time normal, Red blood cell count normal, Restlessness, Ultrasound abdomen abnormal, Vomiting, White blood cell count increased
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Akathisia (broad), Gastrointestinal obstruction (narrow), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Alanine aminotransferase, 13Feb2008, normal; Aspartate aminotransferase, 13Feb2008, normal; Base excess, 13Feb2008, -3.5mmol/l; Blood bicarbonate, 13Feb2008, 19.8mmol/l; Blood electrolytes, 13Feb2008, balanced; Blood glucose, 13Feb2008, 102mg/dl; Body temperature, 13Feb2008, 37.0degC; C-reactive protein, 13Feb2008, 0.2mg/dl; Gamma-glutamyltransferase, 13Feb2008, normal; Hemoglobin, 13Feb2008, normal; Lactate dehydrogenase, 13Feb2008, normal; MCH, 13Feb2008, normal; MCV, 13Feb2008, normal; PCO2, 13 Feb2008, 31.5mmHg; PO2, 13Feb2008, 70.7mmHg; Partial prothrombin time, 13Feb2008, normal; Platelet count, 13Feb2008, normal; Quick''s test, 13Feb2008, normal; Red blood cell count, 13Feb2008, normal; White blood cell count, 13Feb2008, 11.0/nl; pH, 13Feb2008, 7.415; Abdominal sonography, performed on 13 February 2008, Intussusception / invagination at the expected site; Abdominal sonography during enema, performed on 13 February 2008, Rectal filling with pre-warmed NaCl solution up to the head of the invagination without problems, invagination was also driven back by Bauhin''s valve, good filling of the terminal ileal loops, Assessment: disinvagination successful; Abdominal sonography, performed on 14 February 2008, Normal abdominal sonography, especially concerning the intestine, intestinal structures normal except mild oedematous changes, no signs of re-invagination, no ileus.
CDC Split Type: D0056291A

Write-up: This case was reported by a physician via a sales representative and described the occurrence of invagination of intestine in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 28 February 2008, the same case was reported by via regulatory authority ((vaccines, biologicals) #DE-PEI-PEI2008001865). The subject has no underlying or concurrent medical conditions or other risk factors. On 08 February 2008 the subject received the first dose of ROTARIX (1 ml, oral). Approximately five days post vaccination with ROTARIX, on 13 February 2008, the subject experienced invagination of intestine. The subject was hospitalised for an unknown period of time. The reporting physician considered that the event was life threatening. Invagination was confirmed by sonography. Treatment in hospital included disinvagination by giving an enema. After about six hours, on 13 February 2008 or 14 February 2008, the event was resolved. The vaccination course with ROTARIX was discontinued. According to the information received by PEI the reporter considered that the event was probably related to vaccination with ROTARIX. Follow-up information was received on 06 March 2008 by the reporting physician including the hospital report. The subject has no underlying or concurrent medical conditions or other risk factors. The subject received no concomitant medication. On 08 February 2008 the subject received the first dose of ROTARIX (1 ml, oral). On 13 February 2008, the subject experienced invagination of intestine. The subject was hospitalised this event for two days. Anamnesis, according to hospital report: On day prior to invagination of intestine, on 12 February 2008, the subject showed increased restlessness. During night from 12 February 2008 to 13 February 2008 the subject experienced a single episode of splash-like vomiting. The subject was examined by the reporting physician and hospitalised. On admission to hospital, on 13 February 2008, the subject was in satisfactory general condition, experienced no fever (body temperature was 37.0 degC) and showed rosy complexion. Abdominal examination was soft on palpation, showed no pain on pressure and no pathologic resistances. Throat examination was normal. The eardrums were covered with earwax both sides. Lung examination showed vesicular breathing sounds both sides. Heart examination showed clear and rhythmic heart sounds. Laboratory examinations showed C-reactive protein (CRP) of 0.2 mg/dl and white blood cell count of 11.0 /nl. All other laboratory examinations for liver enzymes, blood electrolytes, blood coagulation and blood count were normal. Blood gas analysis showed pH of 7.415, pCO2 of 31.5 mmHg, pO2 of 70.7 mmHg, HCO3 of 19.8 mmol/l, base excess of -3.5 mmol/l, well-balanced electrolytes and blood glucose level of 102 mg/dl. Invagination was confirmed by abdominal sonography. Treatment in hospital included disinvagination by giving an enema with water (pre-warmed NaCl solution). The event resolved without complications. Post disinvagination the subject discharged lots of faeces. Abdominal sonography, performed on 14 February 2008, showed normal intestinal structures except mild oedematous changes, no signs of re-invagination and no ileus. On 14 February 2008, the subject was discharged from hospital in good general condition. No further information will be available. Case D0057465A was identified as a duplicate of case D0056291A and will be voided. All future correspondence will be submitted to the case of Record D0056291A. This subject was enrolled in an epidemiological study to gather epidemiological back-ground data on the incidence of intussusception in foreign country.


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