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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: 312608 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:2008-04-23
Onset:2008-05-04
   Days after vaccination:11
Submitted: 2008-05-19
   Days after onset:15
Entered: 2008-05-19
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
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal pain, Gastrointestinal hypomotility, Haematochezia, Haemoglobin normal, Intussusception, Irritability, Mucous stools, Pain, Surgery, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (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), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 04May2008, see textunit; Hemoglobin, 05May2008, 10.9g/dl
CDC Split Type: B0519907A

Write-up: This case was reported by a physician in the frame of a PASS study and described the occurrence of intussusception in a 2-month-old female subject who was vaccinated with Rotarix (GlaxoSmithKline). The subject was on no other medication and had no relevant medical history nor allergy. Concurrent vaccination included DTaP-IPV-Hib; manufacturer unspecified; intramuscular given on 23 April 2008; Hep B; manufacturer unspecified; intramuscular given on 23 April 2008. On 23 April 2008 the subject received 1st dose of Rotarix (oral). On 4 May 2008, 11 days after vaccination with Rotarix, the subject experienced vomiting and one mucc-sanguinolent stool. The subject was observed at the emergency room with good evolution and the same day she was discharged with paracetamol, diphenidol, chlorpheniramine, erythromycin, ampicillin and ambroxol. Relevant test included abdominal x-ray which showed intestinal loops moved to the left side, lack of air in distal portion and air-fluid levels. Intestinal intussusception was suspected. On 05 May 2008 the subject was re-admitted without improvement and presenting the same signs and symptoms. At physical examination she had irritability, normal pharynx, abdominal distention, absent peristalsis, pain in the right side and rectal tact with expulsion of fresh blood and mucus. The same day the subject underwent a surgery. Ileocecocolic intussusception was found and it was reduced by taxis without complications. The subject presented good evolution. On 08 May 2008 the subject was discharged in good clinical conditions. The subject was treated with amikacin, metronidazole and Metamizole. The physician considered the events were possibly related to vaccination with Rotarix.


VAERS ID: 312613 (history)  
Form: Version 1.0  
Age: 0.5  
Gender: Female  
Location: Foreign  
Vaccinated:2007-09-06
Onset:2007-11-29
   Days after vaccination:84
Submitted: 2008-05-19
   Days after onset:171
Entered: 2008-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Appendicectomy, Appendicitis, Dehydration, Gastrointestinal sounds abnormal, Haematochezia, Haemoglobin increased, Intussusception, Irritability, Lymphocyte count decreased, Mucous stools, Oral intake reduced, Pharyngeal erythema, Surgery, Vomiting, White blood cell count increased, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray 29Nov2007 intussusc.unit; HCV 03Dec2007 26.7pg; Hematocrit 03Dec2007 33.8%; Hemoglobin 03Dec2007 99.2g/dL; Lymphocytes 03Dec2007 23.7%; MCV 03Dec2007 80.3FL; Neutrophils 03Dec2007 67.7%; White blood cells 03Dec2007 12700mm3
CDC Split Type: B0520384A

Write-up: This case was reported by a physician in the frame of a PASS study and described the occurrence of intussusception in a 8-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was on no other medication and had no relevant medical history nor allergy. Previous vaccination included ROTARIX (GlaxoSmithKline, oral) given on 4 May 2007. On 6 September 2007 the subject received 2nd dose of ROTARIX (9 ml, oral, lot number not provided). On 29 November 2007, 84 days after vaccination with ROTARIX, the subject experienced vomiting, irritability, abdominal pain, oral intolerance and bloody mucus in stool. She was admitted in the emergency room the same day. Physical exam showed dehydration, hyperaemic pharynx and intestinal silent. An abdominal X-ray was performed showing invagination. she was hospitalised for 5 days. A surgery was performed on 29 November 2007, ileocecal position and appendicitis were found and resolved by taxis and appendectomy. No complication occurred. The subject showed a good clinical evolution, she was treated with cefotaxime and amikacin (Amikacine) and was discharged on 03 December 2007, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 312636 (history)  
Form: Version 1.0  
Age: 0.6  
Gender: Male  
Location: Foreign  
Vaccinated:2008-03-10
Onset:2008-04-10
   Days after vaccination:31
Submitted: 2008-05-20
   Days after onset:40
Entered: 2008-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Blood thromboplastin decreased, Gastrointestinal hypomotility, Haematochezia, Haematocrit decreased, Haemoglobin decreased, Intestinal anastomosis, Intestinal resection, Intussusception, Irritability, Mucous stools, Pallor, Pathology test, Platelet count increased, Prothrombin time normal, Vomiting
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), 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), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Hematocrit, 11Apr2008, 33.5ml/dl, 37.7 (low), 53.7 (high); Hemoglobin, 11Apr2008, 11.5g/dl, 12.12 (low), 18.10 (high); Pathology test, 14Apr2008, see text unit; Platelet count, 11Apr2008, 537000mm3, 142000 (low), 424000 (high); Prothrombin time, 11Apr2008, 13.1s, 11 (low), 15 (high); Thromboplastin, 11Apr2008, 19.8s, 29.9 (low), 40.70 (high).
CDC Split Type: B0520569A

Write-up: This case was reported by a physician in the frame of a PASS study and described the occurrence of intussusception in a 7-month-old male subject who was vaccinated with ROTARIX, GlaxoSmithKline. The subject was on no other medication and had no relevant medical history nor allergy. Previous vaccination included ROTARIX, GlaxoSmithKline; oral given on 9 January 2008. On 10 March 2008 the subject received 2nd dose of ROTARIX (oral). On 10 April 2008, 31 days after vaccination with the 2nd dose of ROTARIX, the subject started with abdominal pain, vomiting (10 episodes) initially gastric and after biliar, jelly bloody stools (2 episodes). Therefore the subject was brought to the emergency room. Physical examination showed pallor, irritability, abdominal pain, decreased peristalsis no-mass, rectal examination with jelly bloody stools. On 11 April 2008 the subject underwent a surgery where ileocecal intussusception of 10 cm was found. It could not be resolved by taxis therefore intestinal resection of approximately 14 cm was done with termino-terminal anastomosis 12 cm apart from ileocecal valve. No appendectomy was done. After surgery the subject evolved with clinical improvement. On 16 April 2008 the subject was discharged in good clinical conditions. The subject was treated with METAMIZOL, RANITIDINE, FUROSEMIDE and surgery. On 16 April 2008, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 312637 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2008-05-01
Submitted: 2008-05-20
   Days after onset:19
Entered: 2008-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Intestinal resection, Intussusception
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (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: B0520205A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a child subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). This case has been reported to foreign regulatory authorities. The reporter stated that the child''s parent had a previous history of intussusception. On an unspecified date the subject received unspecified dose of ROTARIX (unknown). In May 2008, within 8 days of vaccination with ROTARIX, the subject experienced intussusception. The subject was hospitalised. The subject required bowel resection and remained in hospital. At the time of reporting the outcome of the event was unspecified. The reporter was not the treating physician and any attempts to request further information on this case would require consent from the patient.


VAERS ID: 312638 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:2008-03-14
Onset:0000-00-00
Submitted: 2008-05-20
Entered: 2008-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Dehydration, Diarrhoea, Enema administration, Gastroenteritis rotavirus, Intussusception, Rotavirus test positive, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Dehydration (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: Abdominal X-ray, Mar2008, see textunit; Stool rotavirus antigen positive, May2008, positiveunit
CDC Split Type: B0520071A

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). In March 2008 the subject received 1st dose of ROTARIX (oral). In March 2008, 1-2 weeks after vaccination with ROTARIX, the subject experienced intussusception. Relevant test included abdominal x-ray: plain abdominal radiograph showing a visible intussusception or soft tissue mass; demonstration of the invagination of the intestine by air or liquid contrast enema; plain abdominal radiograph showing non-specific abnormalities. Abdominal ultrasound as well as abdominal computerized tomography scan were not performed. The event was resolved by barium enema close reduction. In April 2008 the subject had vomiting symptoms and the diagnosis of recurrent intussusception was made. The symptom was resolved spontaneously. On 13 May 2008 the subject presented diarrhea. The subject was hospitalised. The stool exam showed positive rotavirus. At the time of reporting the outcome of diarrhea was unspecified. In the follow up received on 16 may 2008 it was specify that the subject was vaccinated on 14 March 2008. The 1st intussusception occurred 11 days after vaccination with 1st dose of ROTARIX. In April 2008 the subject only had vomiting and recurrent intussusception was diagnosed after clinical and physical examination. No imaging studies were performed. It was confirmed that the symptoms was resolved spontaneously. On 13 May 2008 the subject started with diarrhea and the subject was hospitalised due to dehydration. The final diagnosis was Rotavirus gastroenteritis which was resolved on 16 May 2008.


VAERS ID: 312640 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-03-27
Onset:2008-04-01
   Days after vaccination:5
Submitted: 2008-05-20
   Days after onset:49
Entered: 2008-05-20
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, Abdominal rigidity, Crying, Enema administration, Feeding disorder of infancy or early childhood, Haematochezia, Hyperhidrosis, Intussusception, Irritability, Pallor, Screaming, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (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), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 02Apr2008, See text
CDC Split Type: B0520012A

Write-up: This case was reported by a regulatory authority ((clinical) # 016761344) and described the occurrence of intussusception in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 27 March 2008, the subject received unspecified dose of ROTARIX (oral, lot number not provided). On 1 April 2008, 5 days after vaccination with ROTARIX, the subject experienced intussusception. The patient showed crying and screaming in intermittent episodes, pallor and sweating. The abdomen was hard and painful to palpation in right hemi-abdomen. He also showed vomiting, irritability with delay in his feedings and bloody stools. For these reasons he was taken to the Emergency room. The subject was hospitalised. On 2 April 2008, abdominal X-ray was performed and showed compatible findings with intestinal intussusception. Opaque enema was performed: Ileo-ceco-colic intussusception was reduced by hydrostatic pressure, with good oral tolerance 20 hours later. On 3 April 2008, the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with ROTARIX. No further information is expected as this is the only information the Regulatory Authority has, therefore this case has been considered closed.


VAERS ID: 312939 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-05-21
Entered: 2008-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Enema administration, Intestinal resection, Intussusception, Surgery
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0520623A

Write-up: This case was reported in a literature article (conference abstract) and described the occurrence of intussusception in an infant (aged between 2 and 5 months) of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). The study is an investigator-intiated study which is supported by GSK and Merck/CSL. Two rotavirus vaccines, ROTARIX (GSK) and ROTATEQ (Merck) were introduced into the National Immunization Program from July 2007. Whilst these vaccines have been shown to be safe and effective in large clinical trials, post marketing surveillance for intussusception (IS) is essential following the withdrawal of the first rotavirus vaccine (ROTASHIELD) in 1999 due to the documented temporal association between receipt of the vaccine and intussusception. The aim of this study was to estimate the incidence of intussusception, describe treatment used and identify any temporal association with Rotavirus vaccine. Method/Design: Prospective national surveillance of acute intussusception in infants aged less than or equal to 24 months began in May 2007. A monthly report card/e-mail was sent requesting notification of incident IS cases. Questionnaire data were collected to record clinical presentation, diagnosis and management. Results: Of 87 reports to the end of November 2007, 57 (65.5%) completed questionnaires were received and 37 met the case definition criteria. Of the 37 cases, 19 were male, mean age 6 months. Four (11%) children aged between 2 and 5 months had received at least one dose of Rotavirus vaccine 2 weeks prior the development of intussusception. Three of these received ROTATEQ and one received ROTARIX. This case was assessed as medically serious by GSK. In 22 (59.5%) cases intussusception was successfully reduced using air-hydrostatic enema, while 11 (29.7%) required surgical intervention. Of the 11 cases, 8 (72.7%) required partial bowel resection and 7 (63.6%) were found to have a pathological lead point. Conclusions: Concern over the possible association between receipt of rotavirus vaccine and intussusception in 4 of the reported cases. A higher than anticipated rate of surgical intervention for intussusception is concerning and requires further investigation. These preliminary data highlight the need for ongoing surveillance for intussusception. Follow up information received on 16 May 2008: The author has submitted another abstract using similar data which has been accepted as a poster at the International Rotavirus Meeting in June 2008.


VAERS ID: 313535 (history)  
Form: Version 1.0  
Age: 0.25  
Gender: Male  
Location: Foreign  
Vaccinated:2008-03-17
Onset:2008-04-18
   Days after vaccination:32
Submitted: 2008-05-27
   Days after onset:39
Entered: 2008-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Intussusception, Surgery
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? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0522066A

Write-up: This case was reported by a regulatory authority and described the occurrence of intussusception in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). No concomitant medication was reported. On 17 March 2008, the subject received unspecified dose of ROTARIX (oral), lot number not provided. Two days prior to the event onset, the 2 subject''s siblings experienced gastroenteritis. On 18 April 2008, 32 days after vaccination with ROTARIX, the subject experienced intussusception. The regulatory authority reported that the event was clinically significant (or requiring intervention). The subject was treated with surgery. No structural anomaly was detected. At the time of reporting the event was resolved. The regulatory authority reported that the event was probably related to vaccination with ROTARIX.


VAERS ID: 314128 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2008-03-26
Onset:2008-04-07
   Days after vaccination:12
Submitted: 2008-05-29
   Days after onset:52
Entered: 2008-05-29
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, Appendicectomy, Gastrointestinal hypomotility, Haematochezia, Intussusception, Mass, Mucous stools, Obstruction, Surgery, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (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 (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, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 09Apr2008, Abnormalunit
CDC Split Type: B0522174A

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. Previous and/or concurrent vaccination included ROTARIX (GlaxoSmithKline); oral given on 29 January 2008; DTaP/IPV/Hib; manufacturer unspecified; intramuscular; given on 26 March 2008; pneumococcal vaccine; manufacturer unspecified; intramuscular; given on 26 March 2008. On 26 March 2008, the subject received 2nd dose of ROTARIX (oral), lot number not provided. On 7 April 2008, 12 days after vaccination with ROTARIX, the subject experienced 4 times vomiting and stools with mucus and blood. On 9 April 2008, the subject was brought to the emergency room where examination showed abdominal obstruction with decreased bowel peristalsis, dance sign and rectal tact with a palpable mass. Abdominal X-ray showed air fluid levels and abnormal gas distribution without distal air. The subject was hospitalised for 4 days. On 10 April 2008, surgery was performed and cecocolic intussusceptoin was found and resolved by taxis without complication. Furthermore, appendectomy was performed. The subject was treated with paracetamol, AMIKACINE, MECLIZINE, surgery and metronidazole. On 12 April 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: 314129 (history)  
Form: Version 1.0  
Age: 0.5  
Gender: Male  
Location: Foreign  
Vaccinated:2008-04-01
Onset:2008-05-11
   Days after vaccination:40
Submitted: 2008-05-29
   Days after onset:18
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 distension, Abdominal pain, Abnormal faeces, Anorectal disorder, Constipation, Dehydration, Gastrointestinal hypomotility, Haematochezia, Intussusception, Irritability, Mass, Mucous stools, Surgery, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (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), Noninfectious diarrhoea (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 14May2008, showed distended intestinal loops and absent distal air.
CDC Split Type: B0522169A

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 male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history or allergy. Previous vaccination included ROTARIX (GlaxoSmithKline) given on 20 December 2007. On 1 April 2008, the subject received the 2nd dose of ROTARIX (oral, lot number not provided). On 11 May 2008, 40 days after vaccination with the 2nd dose of ROTARIX, the subject experienced alimentary vomiting, intermittent irritability, abdominal pain and absent stool since 3 days before. On 14 May 2008, he was admitted in ER. Physical exam reported dehydration, distended abdomen, mesogastric palpable mass, diminished peristalsis and rectal tract with expulsion of current jelly stool and fresh blood in a second time. The subject was hospitalised. Abdominal X-ray was performed and showed distended intestinal loops and absent distal air. On 14 May 2008, Surgery was performed; ileocecolic intussusception was found, reduction was done without any complications. Post surgical clinical evolution was adequate. The subject was treated with ampicillin, amikacine, metronadizole and paracetamol. On 19 May 2008, the subject was discharged. On 19 May 2008, the events were resolved. The physician considered the events were possibly related to vaccination with ROTARIX.


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http://www.medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=14&SYMPTOMS[]=Intussusception_%2810022863%29&VAX[]=RV1&REPORT_YEAR_LOW=2008&REPORT_MONTH_LOW=02&REPORT_YEAR_HIGH=2014&REPORT_MONTH_HIGH=12


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