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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: 315306 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-04-29
Onset:2008-05-17
   Days after vaccination:18
Submitted: 2008-06-06
   Days after onset:20
Entered: 2008-06-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Barium enema abnormal, CD4 lymphocytes decreased, Haematochezia, Haematocrit decreased, Haemoglobin decreased, Intussusception, Lymphocyte percentage decreased, Mucous stools, Neutrophil count increased, Platelet count normal, Prothrombin time normal, Pyrexia, Rectal haemorrhage, Surgery, White blood cell count increased
SMQs:, Haematopoietic erythropenia (broad), Haematopoietic leukopenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), 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? 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: Barium enema, 17May2008, intussuscept unit; Blood grouping, 17May2008, ORh+unit; Hematocrit, 17May2008, 31.4%, 38 (low), 47 (high); Hemoglobin, 17May2008, 9.43g/dl, 12 (low), 16 (high); Lymphocytes, 17May2008, 15%, 20 (low), 48 (high); Neutrophils, 17May2008, 75%, 40 (low), 70 (high); Platelet count, 17May2008, 354000/mm3, 150000 (low), 450000 (high); Prothrombin time, 17May2008, 11.9 sec, 10.5 (low), 14.5 (high); White blood cells, 17May2008, 18600/mm3, 4500 (low), 10000 (high).
CDC Split Type: B0522871A

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 was under no other medication and had no relevant medical history nor allergy. On 29 April 2008, the subject received 1st dose of ROTARIX (oral), lot number not provided. On 17 May 2008, 18 days after vaccination with ROTARIX, the subject experienced bloody stools like current jelly stool. He was brought to the emergency ward. The physical examination showed fever and rectal bleeding with an abdomen without other clinical sign. Barium enema was performed and confirmed intussusception. On 17 May 2008, surgery was performed and ileocolic intussusception was found and reduced by taxis without complication. The subject was hospitalised for 4 days. The subject was treated with ranitidine hydrochloride, ampicillin sodium, paracetamol, ampicillin trihydrate and vitamin k. On 20 May 2008, the events were resolved and the subject was discharged from hospital. The physician considered the events were possibly related to vaccination with ROTARIX.


VAERS ID: 315309 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Male  
Location: Foreign  
Vaccinated:2008-02-29
Onset:2008-05-08
   Days after vaccination:69
Submitted: 2008-06-06
   Days after onset:29
Entered: 2008-06-06
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, Appendicectomy, Blood glucose normal, Blood potassium decreased, Blood sodium decreased, Blood thromboplastin decreased, Blood urea decreased, Gastrointestinal hypomotility, Haematochezia, Haematocrit decreased, Haemoglobin decreased, Intestinal obstruction, Intussusception, Irritability, Lymphocyte count normal, Neutrophil count normal, Platelet count normal, Prothrombin time normal, Surgery, Transfusion, Ultrasound abdomen abnormal, Vomiting, White blood cell count decreased, X-ray abnormal
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), 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), Hyponatraemia/SIADH (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 09May2008, see text; Blood glucose, 10May2008, 97mg/dl, 65 (low), 99 (high); Hematocrit, 10May2008, 28.6%, 37.7 (low), 53.7 (high); Hemoglobin, 09May2008, 10.3g/dl, 12.2 (low), 18.1 (high); Hemoglobin, 10May 2008, 9.82g/dl, 12.2 (low), 18.1 (high); Leukocyte count NOS, 09May2008, 12500mm3, 4600 (low), 10200 (high); Leukocyte count NOS, 10May2008, 8030mm3, 4600 (low), 10200 (high); Lymphocytes, 10May2008, 38.5%, 10 (low), 50 (high); Neutrophils, 10May2008, 44.9%, 37 (low), 80 (high); Platelet count, 09May2008, 379000mm3, 142000 (low), 424000 (high); Platelet count, 10May2008, 18500mm3, 142000 (low), 424000 (high); Potassium, 09May2008, 34mEq/dl, 3.5 (low), 5.1 (high); Potassium, 10May2008, 4.4mEq/dl, 3.5 (low), 5.1 (high); Prothrombin time, 09May2008, 13.5s, 11 (low), 15 (high); Prothrombin time, 10May2008, 12s, 11 (low), 15 (high); Sodium, 09May2008, 121mEq/dl, 136 (low), 145 (high); Sodium, 10May2008, 131mEq/dl, 136 (low), 145 (high); Stool analysis, 09May2008, see text; Thromboplastin, 09May2008, 23.1s, 29.9 (low), 40.7 (high); Thromboplastin, 10May2008, 26.4s, 29.9 (low), 40.7 (high); Ultrasound abdomen, 10May2008 ISunit; Urea, 10May2008, 6mg/dl, 7 (low), 18 (high).
CDC Split Type: B0523636A

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 male subject who was vaccinated with ROTARIX, GlaxoSmithKline. The subject did not have any relevant medical history. Previous and/or concurrent vaccination included ROTARIX; GlaxoSmithKline; oral given on 19 December 2007. On 29 February 2008 the subject received 2nd dose of ROTARIX. On 8 May 2008, 69 days after vaccination with ROTARIX, the subject experienced irritability, vomiting (2 episodes, one episode with bilis) and bloody stool. The subject was brought to emergency room with abdominal distension, without peristalsis and blood stain through anal examination. On 09 May 2008 relevant test included abdominal x-ray compatible with intestinal obstruction. On 10 May 2008 abdominal ultrasound confirmed intussusception. The same day the subject was hospitalised and abdominal surgery was performed. At surgery ileo-ileo-cecal intussusception was found and it was reduced by taxis without complications. Appendectomy was also done. After surgery the subject evolved slowly to clinical improvement. On 14 May 2008 the subject was discharged in good clinical conditions. The subject was treated with ranitidine hydrochloride, red blood cells and omeprazole. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 315531 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-05-05
Onset:2008-05-10
   Days after vaccination:5
Submitted: 2008-06-06
   Days after onset:27
Entered: 2008-06-09
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Barium enema, Intussusception, Ultrasound scan normal
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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Barium enema of opaque colon (results: quick filling of all the colic frame, which has a normal magnitude and structure. The valve passes well and 15 cm of terminal ileus. No existence of invagination.) and ultrasound scan (results: no findings) were done on 12-May-2008.
CDC Split Type: ESWYEG01638908

Write-up: Information regarding PREVENAR was received from a healthcare professional via a regulatory authority regarding a 3-month-old male patient who experienced intussusception. The patient received a dose on 05-May-2008. The patient experienced intussusception on 10-May-2008. The patient was hospitalized. On 12-May-2008 the patient was spontaneously recovered. No additional information was available at the time of this report.


VAERS ID: 316515 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-04-17
Onset:2008-05-14
   Days after vaccination:27
Submitted: 2008-06-18
   Days after onset:35
Entered: 2008-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Blood creatinine normal, Blood gases abnormal, Blood glucose normal, Blood potassium normal, Blood sodium increased, Gastrointestinal hypermotility, Haematochezia, Haematocrit normal, Haemoglobin normal, Ileus, Intestinal ischaemia, Intussusception, Lymphadenopathy, Lymphocyte percentage decreased, Nausea, Neutrophil percentage increased, Platelet count normal, Pyrexia, Surgery, White blood cell count normal
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (broad), Lactic acidosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (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, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood glucose, 19May2008, 394mg/dl, 70-990; Creatine, 19May2008,0.3mg/dl, 0.9-0.6; Hematocrit, 19May2008,30.4%,30-42; Hemoglobin, 19May2008, 10.4g/dl, 10-13; Lymphocytes, 19May2008, 33.3%, 41-71; Neutrophils, 19May2008, 55.3%, 13-33; Platelet count, 19May2008, 433.000mm3, 300.000-700.000; Potassium, 19May2008, 3.6mEq/h, 3.5-5.5; Sodium, 19May2008, 943mEq/h, 135-145; White blood cells, 19May2008, 13.20mm3, 6.000-17.500; X-ray abdominal on 19 May 2008: lack of distal air and abdomen distribution of intestinal gas.
CDC Split Type: B0524583A

Write-up: On 18 February 2008, the subject received the first dose of ROTARIX vaccine. On 17 April 2008, the subject received the second dose of ROTARIX vaccine. 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). The subject had no relevant medical history. No concomitant medication given. On 17 April 2008, the subject received 2nd dose of ROTARIX (oral). On 14 May 2008, 27 days after 2nd vaccination with ROTARIX, the subject experienced intussusception, adenomegaly, nausea, hyperperistalsis, hematochezia, fever, blood present in stool and ileus. The subject was hospitalised. Relevant test results included x-ray abdominal evidenced lack of distal air and abnormal distribution of intestinal gas. Intussusception was suspected and surgery was done on 19 May 2008, small bowel loops and colon exploration was done. Finding intestinal ischemia with vascular recuperation and mesenteric adenopathy, intestinal resection was not necessary, the surgeon confirmed that intussusception has spontaneous resolution. The subject showed Ileus after abdominal surgery, however the clinical evolution evidenced improvement without complication. The subject was treated with paracetamol, ranitidine, metamizol, clindamycin and amikacin. On 23 May 2008, the events were resolved. He was discharged with diagnosis of intestinal invagination on 23 May 2008, with good oral acceptance, digestion favorable and normal colonic function. Other diagnosis at discharge was adenomegaly mesenteric. The physician considered the events were related to vaccination with ROTARIX.


VAERS ID: 316516 (history)  
Form: Version 1.0  
Age: 0.5  
Gender: Female  
Location: Foreign  
Vaccinated:2008-04-11
Onset:2008-05-23
   Days after vaccination:42
Submitted: 2008-06-18
   Days after onset:26
Entered: 2008-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Appendicectomy, Gastrointestinal sounds abnormal, Haematochezia, Intussusception, Irritability, Surgery, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), 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), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0524213A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of ileocolic intussusception in a 7-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (intramuscular) given on 7 May 2008; hepatitis B vaccine recombinant (intramuscular) given on 7 May 2008. First ROTARIX dose was given on 2 January 2008. On 11 April 2008, the subject received 2nd dose of ROTARIX (1 ml, oral). Lot number not provided. On 23 May 2008, 42 days after 2nd vaccination with ROTARIX, the subject experienced ileocolic intussusception, irritability, vomiting, bloody stools, bowel sounds decreased, current jelly stool. On 24 May 2008, a surgery was performed and yeyuno-ileo-ceco-colin intussusception was found without vascular compromise, reduction by taxis and prophylactic appendectomy was done with success. Post surgical clinical evolution was favorable, finally, she was discharged in good clinical condition. No laboratory and radiographics exams were reported in the clinical file. The subject was hospitalised for 5 days. The subject was treated with AMPICILLIN. On 27 May 2008, the events were resolved. The physician considered the events were not related to vaccination with ROTARIX.


VAERS ID: 316665 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Male  
Location: Foreign  
Vaccinated:2008-04-08
Onset:2008-05-22
   Days after vaccination:44
Submitted: 2008-06-19
   Days after onset:28
Entered: 2008-06-19
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 mass, Abdominal pain, Appendicectomy, Crying, Dehydration, Gastrointestinal hypermotility, Haematochezia, Hyperaemia, Intussusception, Mucous stools, Oedema, Pyrexia, Surgery, Vomiting, X-ray abnormal
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (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, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal x ray showed scarce distal air and air-fluid levels.
CDC Split Type: B0523639A

Write-up: This case was reported by a physician in the frame of study and described the occurrence of intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included first dose of ROTARIX given on 8 February 2008. On 8 April 2008, the subject received 2nd dose of ROTARIX (1 ml, oral). On 22 May 2008, 44 days after vaccination with ROTARIX, the subject experienced intussusception, crying, vomiting, bloody stools, mucus in stool, fever, pharyngeal hyperemia, abdominal pain, bowel peristalsis increased, current jelly stool, abdominal mass, dehydration, edema and hyperemia. The subject was hospitalised for 5 days. Relevant test results included abdominal x ray that showed scarce distal air and air-fluid levels. The subject was treated with cefotaxime, ranitidine, metamizole, ketorolac, nalbuphine, paracetamol and surgery. Surgery was performed on 23 May 2008, ileocolic invagination was found and corrected with the pharmacologic relaxation during surgery, besides, appendectomy was also done because it has hyperemia and edema. On 27 May 2008, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 316666 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Female  
Location: Foreign  
Vaccinated:2008-03-24
Onset:2008-05-06
   Days after vaccination:43
Submitted: 2008-06-19
   Days after onset:44
Entered: 2008-06-19
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, Blood potassium increased, Blood sodium decreased, Dehydration, Haematochezia, Haematocrit normal, Haemoglobin normal, Intestinal obstruction, Intussusception, Nausea, Neutrophil percentage increased, Pallor, Platelet count normal, Pyrexia, Surgery, Tachycardia, Vomiting, White blood cell count normal, 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), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), 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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Hematocrit, 08May2008, 34.7%; Hemoglobin, 08May2008, 12.5g/dl; Neutrophils, 08May2008, 48%; Platelet count, 08May2008, 445mm3; Potassium, 08May2008, 6.4Eq/l; Sodium, 08May2008, 134.6Eq/l; White blood cells, 08May2008, 11.100mm3; x-ray abdomen: showed air fluid levels, dilated intestinal loops and absent distal gas.
CDC Split Type: B0524126A

Write-up: This case was reported by a physician in the frame of study and described the occurrence of ileocecal obstruction in a 6-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 24 March 2008 the subject received 2nd dose of ROTARIX (oral). On 6 May 2008, 43 days after vaccination with ROTARIX, the subject experienced ileocolic intussusception, blood in stool(s), abdominal distension, vomiting (8 times), fever, nausea, inability to pass flatus (abdominal distention gaseous), dehydration, pallor, tachycardia and abdominal pain. The subject was hospitalised on 8 May 2008. Urgent surgery was done ileocolic intussusception was found with perforation at 15cm of ileocecal valve (distal ileon), resection with term to term anastomosis of this portion of ileon (2cm approximately) was performed, no other complication was found. Postsurgical recuperation was slowly, finally was discharged on 15 May 2008. Lab test were performed. The subject was treated with amikacine, dimenhydrinate, paracetamol, cefoxtamine and metamizole. On 15 May 2008, the event was resolved. The physician considered the event was unrelated to vaccination with ROTARIX.


VAERS ID: 316757 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Foreign  
Vaccinated:2007-05-22
Onset:2007-06-01
   Days after vaccination:10
Submitted: 2008-06-20
   Days after onset:385
Entered: 2008-06-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Enema administration, Haematochezia, Intussusception, Megacolon, Pain, Ultrasound abdomen abnormal, Vomiting
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), 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: Ultrasound abdomen, 09Jun2007, Abnormal
CDC Split Type: B0477134A

Write-up: This case was reported by a physician and described the occurrence of intussusception of intestine in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 22 May 2007, the subject received a dose of ROTARIX (batch number not available, oral). At an unspecified date later, he presented with serious bloody stools, vomiting and pain. The subject was hospitalised. On 09 June 2007, an abdomen ultrasound was performed. Diagnosis of intussusception of intestine was made. Under enema with hydrosolubles, a colo-colic desinvagination was performed with mild difficulties. According to the radiologist, the subject had a megacolon. Within an unspecified delay, the events resolved. The reporter''s causality assessment was unknown. Follow up on 11 June 2008: This case has been closed. No more information will be available.


VAERS ID: 316965 (history)  
Form: Version 1.0  
Age: 0.5  
Gender: Male  
Location: Foreign  
Vaccinated:2008-01-30
Onset:2008-02-27
   Days after vaccination:28
Submitted: 2008-06-23
   Days after onset:116
Entered: 2008-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Breast feeding, Intestinal mass, Intestinal resection, Intussusception, Irritability, Lethargy, Pallor, Rectal haemorrhage, Ultrasound abdomen abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Gastroesophageal reflux
Allergies:
Diagnostic Lab Data: Ultrasound abdomen, Feb2008, IS
CDC Split Type: B0525609A

Write-up: This case was reported by a healthcare professional and described the occurrence of intussusception in a 7-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). This case is one of 4 cases collected through a study occurring post ROTARIX vaccination since August 2007. The subject was born at term. The subject''s birth weight was 2.6 Kg. The subject''s medical history included gastroesophageal reflux. The subject had no history of intussusception. The subject had no family history of intussusception. The subject had no current medications or traditional medicines. Feeding history: The subject currently fed breast milk. There was no change to the subject''s diet in the last week. The subject had feeding intolerance/food sensitivities (gastroesophageal reflux disease). Previous vaccination included ROTARIX (GlaxoSmithKline; unknown) given on 19 October 2007. On 30 January 2008, the subject received 2nd dose of ROTARIX (unknown). On 27 February 2008, 28 days after vaccination with the 2nd dose of ROTARIX, the subject experienced intussusception. He experienced the following symptoms: abdominal pain, vomiting, lethargy, pallor, irritability, intestinal mass and passage of blood per rectum. No faeces''s sample was collected. The diagnosis of intussusception was made based on abdominal ultrasound exam (site of IS; ascending colon). The subject was treated with air/hydrostatic Enema. Surgical resection was performed. The lead point or other pathology have not been identified. This case was assessed as medically serious by GSK. On 03 March 2008, the subject was discharged. At the time of reporting the outcome of the events was unspecified.


VAERS ID: 316966 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Foreign  
Vaccinated:2008-03-27
Onset:2008-04-03
   Days after vaccination:7
Submitted: 2008-06-23
   Days after onset:81
Entered: 2008-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal pain, Breast feeding, Familial risk factor, Gastrointestinal sounds abnormal, Intestinal obstruction, Intestinal resection, Intussusception, Irritability, Lethargy, Pallor, Rotavirus test positive, Ultrasound abdomen abnormal, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (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? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, Apr2008, Fluid level; Rotavirus test, 06Apr2008, Positive; Ultrasound abdomen, Apr2008, IS
CDC Split Type: B0525608A

Write-up: This case was reported by a healthcare professional and described the occurrence of intussusception in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). This case is one of 4 cases collected through a study occurring post ROTARIX vaccination since August 2007. The subject was born at term. The subject''s birth weight is 4.22 Kg. The subject had no history of intussusception. The subject had no previous significant illness/ hospitalisations/ operations. The subject had a family history of intussusception. Feeding history: The subject currently fed breast milk and formula. There was no change to the subject''s diet in the last week. The subject had no feeding intolerance or food sensitivities. The subject received current medications or traditional medicines. Previous and/or concurrent vaccination included Hib (manufacturer unspecified; unknown) given on an unspecified date; DTaP (manufacturer unspecified; unknown) given on an unspecified date; Hep B (manufacturer unspecified; unknown) given on an unspecified date; pneumococcal vaccine, unspecified (manufacturer unspecified; unknown0 given on an unspecified date. On 27 March 2008, the subject received the 1st dose of ROTARIX (unknown). On 3 April 2008, 7 days after vaccination with ROTARIX, the subject experienced intussusception; He experienced the following symptoms: abdominal pain, vomiting, lethargy, pallor, irritability, intestinal obstruction; acute abdominal distention and abnormal or absent bowel sounds. Abdominal X-ray showed fluid level. The diagnosis of intussusception was made based on abdominal ultrasound exam (site of IS: Hepatic flexure; Type of IS: ileocaecal). On 06 April 2008, faeces''s sample was collected; RNA Rotavirus test was positive. The subject required surgical resection. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.


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