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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: 337733 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Female  
Location: Foreign  
Vaccinated:2008-11-10
Onset:2008-12-11
   Days after vaccination:31
Submitted: 2009-01-20
   Days after onset:40
Entered: 2009-01-20
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, Constipation, Dehydration, Gastrointestinal sounds abnormal, Haematochezia, Intussusception, Irritability, Laparotomy, Mucous stools, Nausea, Pallor, 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 (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), 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, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Broncholitis
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 13Dec2008, suggested intestinal obstruction.
CDC Split Type: B0552904A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 5-month-old female subject who was vaccinated with ROTARIX. The subject''s medical history included bronchiolitis. The subject was admitted at ER; she received unknown treatment and was discharged. Bronchiolitis started and finished one week earlier. Previous vaccination included ROTARIX (oral) given on 8 September 2008. On 10 November 2008, the subject received the 2nd dose of ROTARIX (oral, lot number not provided). On 11 December 2008, 31 days after vaccination with ROTARIX, the subject experienced abdominal pain, nausea, vomiting, irritability, bloody stools and constipation. On 13 December 2008, the subject was admitted at ER, Physical exam reported irritablilty, abdominal pain, dehydration, sausage chapped abdominal mass, current jelly stool with pallor and decreased bowel sounds. The subject was hospitalised. Abdominal X-ray suggested intestinal obstruction. Laparatomy was made on 14 December 2008; Ileocecal intussusception was found and resolved by taxis, prophylactic appendectomy was done without complications. The subject was treated with Ampicillin and Paracetamol. After a full recovery the subject was discharged on 17 December 2008 in good clinical conditions. On 17 December 2008, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 337734 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-08-01
Onset:2008-12-25
   Days after vaccination:146
Submitted: 2009-01-20
   Days after onset:26
Entered: 2009-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Activated partial thromboplastin time shortened, Blood creatinine normal, Blood glucose increased, Blood potassium normal, Blood sodium normal, Blood urea normal, Gastrointestinal sounds abnormal, Haematochezia, Haemoglobin normal, Intussusception, Irritability, Laparotomy, Mucous stools, Nausea, Neutrophil percentage increased, Platelet count normal, Prothrombin time normal, Vomiting, White blood cell count normal, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), 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, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Activated partial thromboplast, 26Dec2008, 23.3Seconds; Blood glucose, 26Dec2008, 128mg/dL; Blood urea nitrogen, 26Dec2008, 13mg/dL; Creatinine, 26Dec2008, 0.3mg/dL; Hemoglobin, 26Dec2008, 12mg/dL; Neutrophil percentage, 26Dec2008, 77%; Platelet count, 26Dec2008, 400000IU; Potassium, 26Dec2008, 4.6meq/dL; Prothrombin time, 26Dec2008, 12.5Seconds; Sodium, 26Dec2008, 141mEq/dL; White blood cell count, 26Dec2008, 15800IU
CDC Split Type: B0553181A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in an 8-month-old male subject who was vaccinated with ROTARIX (oral) given on 9 June 2008. The subject was previously healthy; he had no relevant medical history or allergy. Previous vaccination included ROTARIX (GlaxoSmithKline). On 1 August 2008, the subject received the 2nd dose of ROTARIX (oral, lot number not provided). On 25 December 2008, 5 months after vaccination with the 2nd dose of ROTARIX, the subject experienced abdominal pain, nausea, vomiting and irritability. On 26 December 2008, the subject was admitted at ER. Physical exam reported vomiting, current jelly stool and decreased bowel sounds. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). Lab tests were performed and showed the following: Leucocytes: 15800 IU; Neutrophils: 77%; Platelets: 400000 IU; Hemoglobin: 12 mg/dL; Prothrombin time: 12.5 Seconds: Partial thromboplastin time: 23.3 Seconds; Sodium: 141 mEq/dL; Potassium: 4.6 mEq/dL; BUN: 13 mg/dL; Creatinine: 0.3 mg/dL; Glucose: 128 mg/dL. X-ray was performed and showed intestinal loops distention and bad gas distribution. Intussusception was suspected and confirmed by laparatomy on 27 December 2008. Ileocecocolic intussusception was found and reduced by taxis without complications. The subject was treated with Ranitidine. After recovery, the subject was discharged on 30 December 2008 in good clinical conditions. On 30 December 2008, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 337846 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-07-01
Onset:2009-01-02
   Days after vaccination:185
Submitted: 2009-01-21
   Days after onset:19
Entered: 2009-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Band neutrophil percentage increased, Dehydration, Food intolerance, Haematocrit decreased, Haemoglobin decreased, Intussusception, Lymphadenitis, Neutrophil percentage, Pyrexia, Surgery, Varicella, Vomiting, White blood cell count increased, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 03Jan2009, IS; Band neutrophil percentage 03Jan2009, 5%; Band neutrophil percentage, 03Jan2009, 5%; Hematocrit, 03Jan2009, 29%; Hematocrit, 03Jan2009, 34.2%; Hemoglobin, 03Jan2009, 11.2g/dl; Hemoglobin, 03Jan2009, 9.7g/dl; Leukocyte count NOS, 03Jan2009, 7.2mm3; Leukocyte count NOS, 03Jan2009, 17.5mm3; Neutrophils, 03Jan2009, 70%; Neutrophils, 03Jan2009, 52%
CDC Split Type: B0554110A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 10-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included ROTARIX; GlaxoSmithKline; oral given on 25 April 2008. On 1 July 2008 the subject received 2nd dose of ROTARIX (oral). On 2 January 2009, 6 months after vaccination with ROTARIX, the subject was hospitalized because he presented fever frequent vomiting and food intolerance. Physical examination showed lesions of varicella not complicated, fever and dehydration. Relevant test performed 2 hours later included abdominal x-ray which showed air fluid levels, generalized opacity in mesogastry, and lack of air in rectal ampulla. Therefore intestinal invagination was suspected. On 03 January 2009 a surgery was performed corroborating ileo-ileal intussusception with mesenteric adenitis and normal cecolappendix. The event was resolved without complications and franc improvement. On 08 January 2009 the subject was discharged. The subject was hospitalized for 7 days. The subject was treated with Ampicillin and paracetamol. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 338133 (history)  
Form: Version 1.0  
Age: 0.6  
Gender: Male  
Location: Foreign  
Vaccinated:2008-10-16
Onset:2008-12-18
   Days after vaccination:63
Submitted: 2009-01-23
   Days after onset:36
Entered: 2009-01-23
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, Asthenia, Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood potassium normal, Blood sodium normal, Blood urea increased, Intestinal obstruction, Intussusception, Irritability, Lymphocyte count normal, Neutrophil count increased, Platelet count increased, Prothrombin time prolonged, Pyrexia, Rectal haemorrhage, Surgery, Vomiting, White blood cell count increased, X-ray abnormal
SMQs:, Acute renal failure (broad), Liver-related coagulation and bleeding disturbances (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? 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, 18Dec2008, Abnormal; Blood glucose, 18Dec2008, 90mg/dl; Chloride, 18Dec2008, 110.7mEq/L; Creatinine, 18Dec2008, 0.3mg/dl; Leukocyte count NOS, 18Dec2008, 11000/mm3; Lymphocytes, 18Dec2008, 21.6%; Neutrophils, 18Dec2008, 74.9%; Platelet count, 18Dec2008, 574000/mm3; Potassium, 18Dec2008, 4.56mEq/L; Protrombin time, 18Dec2008, 15 sec; Sodium, 18Dec2008, 141mEq/L; Urea, 18Dec2008, 27mg/dl
CDC Split Type: B0554122A

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 male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was under no other medication and had no relevant medical history nor allergy. He was previously healthy. Previous and/or concurrent vaccination included ROTARIX;GlaxoSmithKline;oral given on 24 July 2008. On 16 October 2008, the subject received 2nd dose of ROTARIX (oral). On 18 December 2008, 63 days after vaccination with 2nd dose of ROTARIX, the subject experienced 7 times biliary vomitings with abdominal pain, asthenia, irritability, adynamia and and fever. The subject was brought to emergency ward. The laboratory test showed partial thromboplastine time 36.6 sec. The physical examination showed abdomen without peristalsis, rectal tact with bleeding and finger exploration with fresh blood. The abdominal X-ray showed an intestinal obstruction and air-fluid levels. Intussusception was suspected. The subject was hospitalised for 5 days. On 19 December 2008, a surgery was performed and an ileocecocolic intussusception was found and reduced by taxis without complication. The subject was treated with amikacin, metronidazole, DIMENHYDRINAT, paracetamol and ambroxol. On 22 December 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: 338626 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2009-01-16
Onset:2009-01-19
   Days after vaccination:3
Submitted: 2009-01-29
   Days after onset:10
Entered: 2009-01-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Blood culture negative, Blood electrolytes normal, Full blood count normal, Haematochezia, Intussusception, Laparotomy, Mucous stools, Pyrexia, Ultrasound abdomen abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), 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, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood culture, Jan2009, normal; Complete blood count, Jan2009, normal; Serum electrolytes NOS, Jan2009, normal; Ultrasound abdomen, Jan2009, abnormal
CDC Split Type: B0556171A

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. The subject had no relevant medical history. On 16 January 2009, the subject received 2nd dose of ROTARIX (1 ml, oral). Lot number not provided. On 19 January 2009, 3 days after vaccination with ROTARIX, the subject was taken to hospital with fever and abdominal distension. The initial diagnosis was conscience disorder but the occurrence of 2 bloody stools like jelly corroborated the diagnosis of intussusception which was confirmed by abdominal ultrasound. The subject was hospitalized and the physician considered the events were clinically significant (or requiring intervention). Laboratory tests were performed and showed the following: Serum electrolytes: normal; Blood culture: normal; Complete blood count: normal. Abdominal ultrasound showed visible intussusception or soft tissue mass. Abdominal X-ray and air or liquid contrast Enema were not done in diagnostic procedures. The surgery was done by laparotomy and intussusception was resolved without intestinal resection and complication. The patient had good response and favorable evolution. On 22 January 2009, the events were resolved and the patient was discharged. The physician considered the events were possibly related to vaccination with ROTARIX.


VAERS ID: 339377 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Unknown  
Location: Foreign  
Vaccinated:2009-01-10
Onset:2009-01-11
   Days after vaccination:1
Submitted: 2009-02-10
   Days after onset:30
Entered: 2009-02-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Decreased appetite, Intestinal perforation, Intestinal resection, Intussusception, Pain, Regurgitation, Surgery
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal perforation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
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: UNK
CDC Split Type: B0558583A

Write-up: This case was reported by a consumer and described the occurrence of regurgitation in a subject of unspecified age and gender who was vaccinated with ROTARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 10 January 2009 the subject received 1st dose of ROTARIX (oral). On 11 January 2009, 1 day after vaccination with ROTARIX, the subject experienced regurgitation and pain. On 13 January 2009 the regurgitations became yellow. On 14 January 2009 the regurgitations were more yellow and the subject did not eat in the evening. On 15 January 2009 the subject visited the emergency room and was hospitalised. A diagnosis of intussusception was made and the subject underwent surgery due to intestinal perforation. The subject was discharged from hospital on an unknown date. At the time of reporting the outcome of the events was unspecified. Verbatim text received: Her infant received a first dose of ROTARIX oral (batch unk) on 10 January 2009, administered by a foreign paediatrician. Then she went out of town (unspecified date). On 11 January 2009, the subject had more regurgitations than usual and pain. On 13 January 2009, yellow regurgitations. On 14 January 2009, regurgitations were more yellow. The subject did not eat in the evening. On 15 January 2009, went to emergency room + hospitalisation. Diagnosis of Intussusception and surgery due to perforation of intestine. Intestine resection. The subject has been discharged from hospital at an unspecified date. Past medical condition of the subject: no intussusception, no known intestine malformation, no constipation, no diarrhea. One hour after each bottle feed, the subject cried since birthdate. No family history of intestine malformation or intussusception.


VAERS ID: 339604 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:2008-07-24
Onset:2008-08-27
   Days after vaccination:34
Submitted: 2009-02-13
   Days after onset:170
Entered: 2009-02-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal mass, Asthenia, Body temperature increased, Crying, Enema administration, Gastrointestinal tube insertion, Haematochezia, Heart rate increased, Intussusception, Lethargy, Moaning, Pyrexia, Ultrasound abdomen abnormal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ischaemic colitis (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
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: Body temperature, 27Aug2008, 38 deg. C; Body temperature, 28Aug2008, 38.7 deg. C; Ultrasound abdomen, 28Aug2008, IS
CDC Split Type: B0558279A

Write-up: This case was reported by a regulatory authority (#FI-NAM-20090077) and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject is the second child in the family. The subject''s mother had normal pregnancy. Cesarean section was planned because the mother''s previous childbirth experienced was a rough vacuum extraction. Birth weight: 3,940g. The baby has grown well so far and was on breast milk. She had a bowel movement every 4 days and had a large one a day before the onset date. On 24 July 2008, the subject received the 1st dose of ROTARIX (oral, lot number not provided). On 27August2008, 34 days after vaccination with ROTARIX, the subject the child started to cry in a shrieking manner, moaned all night and had a fever (38 deg. C). They came to the doctor, who noticed that the child was weak and lethargic, conscious and followed with her eyes. There was a fair amount of blood in the nappy. She was sent to the emergency for suspected intestinal invagination. The subject arrived on referral by doctor due to suspected invagination. The subject was hospitalized. General condition was moderate. Body temperature was 38.7 deg. C, blood pressure has not been taken yet. The girl was a little lethargic. However, she grabbed with her hands, the fontanelle was not bulging, followed with her eyes. A rapid heartbeat during auscultation, no murmurs. Symmetrical respiration sounds upon lung auscultation. The abdomen was soft and compliant during palpation; there was a sausage-like palpable mass on the lower abdomen. The liver seemed to be in the costal arch . A. fem. +/+. Normal skin turgor, warm periphery. Good capillary filling. The nappy was was full of bright blood. No tenderness during palpation per rectum, normal tonus. There was no blood on the glove. Clean anal region, no cuts during inspection. Specialist has also seen the subject. Clean skin. Blood samples and blood cultivation were taken. Abdominal ultrasound was ordered. There was clear finding indicating invagination. Plenty of retention in the ventricle. A nasogastric tube has been inserted. An air enema was successfully completed under general anesthesia. Most likely it was ileocecal invagination. The subject was transferred to be monitored in the recovery room. On 29 August 2008, the subject was discharged. At the time of reporting the outcome of the events was unspecified. Follow up at clinic in two months. This is all information received and available about this case. This case has therefore been considered closed.


VAERS ID: 339735 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Foreign  
Vaccinated:2008-11-06
Onset:2008-11-10
   Days after vaccination:4
Submitted: 2009-02-17
   Days after onset:99
Entered: 2009-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Diarrhoea haemorrhagic, Echography abnormal, Fluid intake reduced, Haemoglobin decreased, Intussusception, Surgery, Ultrasound abdomen abnormal, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cleft lip
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 11Nov2008, IS; Echography, 11Nov2008, IS; Hemoglobin, 11Nov2008, 9.39%; Ultrasound abdomen, 11Nov2008, IS
CDC Split Type: B0546482A

Write-up: This case was reported by a physician via sales representative and described the occurrence of intussusception in a 9-week-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 6 November 2008 the subject received unspecified dose of ROTARIX (unknown), lot number unknown. The subject experienced intussusception. Therefore on 11 November 2008 the subject underwent a surgery. At the time of reporting the outcome of the event was unspecified. Follow up received on 07 January 2008: Subject''s family history did not include intussusception or bowel abnormalities. The subject did not have previous intra-abdominal surgery. On 11 November 2008 the subject onset ileocolic intussusception till spleen angle. Relevant test performed on 11 November included abdominal X-ray which confirmed intussusception and showed fluid levels and dilated bowel loops; the abdominal ultrasound showed visible intussusception. The same day the subject underwent a surgery. No resection was required. The subject survived. The vaccination with ROTARIX was discontinued. The outcome of the event remained unspecified. Follow up received on 10 February 2009: On 10 November 2008 the subject started vomiting and not drank anymore in the night. On 11 November 2008 the subject had bloody diarrhea and afterwards passive ++. Therefore he was brought to the emergency department. Relevant test included also echo abdomen and contrast enema. On 18 November 2008 the subject was discharged in good general conditions. On 25 November 2008 the subject underwent a control. The subject was fully recovered.


VAERS ID: 340131 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Male  
Location: Foreign  
Vaccinated:2007-02-07
Onset:2007-02-26
   Days after vaccination:19
Submitted: 2009-02-19
   Days after onset:724
Entered: 2009-02-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA158E / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Ascites, Band neutrophil percentage increased, Base excess negative, Blood bicarbonate normal, Blood culture negative, Blood pH normal, Body temperature increased, Bronchitis, C-reactive protein increased, Contusion, Crying, Diarrhoea, Diet refusal, Fall, Gastroenteritis, General physical health deterioration, Haematochezia, Haematocrit normal, Haemoglobin normal, Hypotonia, Ileus, Intussusception, Mouth haemorrhage, Neutrophil percentage decreased, PCO2 normal, Pallor, Platelet count increased, Rotavirus test positive, Small intestinal resection, Ultrasound abdomen abnormal, Urine ketone body present, Vomiting, White blood cell count increased
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Haematopoietic leukopenia (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), 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), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Acetone urine, 26Feb2007, ++; Band neutrophil percentage, 2007, 6%; Base excess, 26Feb2007, -3.3mmol/l; Blood bicarbonate, 26Feb2007, 21.5; Blood culture, 26Feb2007, sterile; Blood pH, 26Feb2007, 7.37; Body temperature, 26Feb2007, 37.9deg C; C-reactive protein, 2007, 35.6mg/l; C-reactive protein, 26Feb2007, 11.4mg/l; Head circumference, 26Feb2007, 46.5cm; Hematocrit, 26Feb2007, 34.4%; Hemoglobin, 26Feb2007, 11.4g/dl; PCO2, 26Feb2007, 37.7mm Hg; Platelet count, 26Feb2007, 547000/ul; Segmented neutrophil percentage, 2007, 38%; Stool rotavirus antigen positi, 26Feb2007, negative; White blood cell count, 2007, 20000/ul; White blood cell count, 26Feb2007, 10300/ul; Abdominal ultrasound scan, performed on 27 February 2007: Ileocolic invagination (intussusception) in the right epigastric region with ileus and distinct ascites. Intestinal loops were in parts floating in free fluid. Fluid and lymph nodes were also detected in invagination. Abdominal ultrasound scan, performed on 02 March 2007: Only very little inter-enteric fluid; little peristalsis in the right abdomen; well filled intestinal loops on the left side with fluid ingesta and active peristalsis; no signs of thickening of the intestinal walls, pathologic intestinal alterations ("Kokarde") or re-invagination (re-intussusception).
CDC Split Type: D0053571A

Write-up: This subject was enrolled in foreign study to gather epidemiological back-ground data on the incidence of intussusception in a foreign country. This report describes the occurrence of ileocolic intussusception in a 6-month-old male subject who was vaccinated with ROTARIX. The subject''s family anamnesis is free of intussusception and any other intestinal disorders. The subject experienced no intestinal birth-defects. The subject''s medical history did not include any intraabdominal surgeries previously. According to follow-up information, received on 22 June 2007 by a physician who was not the vaccinating physician, the subject received the first dose of ROTARIX on 30 December 2006. Approximately 58 days later, on 26 February 2007, the subject was diagnosed with ileocolic intussusception. The subject was hospitalized and underwent fixation of ileus. On 05 March 2007 the events were resolved. The reporting physician, who was not the vaccinating physician, considered that the events were life-threatening. Follow-up information by the treating physician, including the hospital report, was received on 26 July 2007. According to this information the subject received the first and only dose of ROTARIX on 11 January 2007. This information was confirmed by supplying additional information including the lot number of ROTARIX. This information was confirmed on 20 August 2007 by phone. Approximately 46 days post vaccination with ROTARIX, on 26 February 2007, the subject was diagnosed with ileocolic intussusception. The hospital report described the events as follows: In the morning of 26 February 2007 the subject fell off his mother''s bed. The subject was crying for a while, but falling asleep again after a while. Then waking up again the subject was limp, refused drinking and was bleeding from the mouth. On examination by a physician, the subject was vomiting once and showed facial pallor. On the same day, on 26 February 2007, the subject was hospitalized for suspected commotio cerebri. Brain concussion was not verified. According to the hospital report the subject was diagnosed with bruise of head, intussusception, gastroenteritis and obstructive bronchitis. On admission to hospital, on 26 February 2007, the subject showed significantly reduced general condition and pallor. Traumatic signs were noticed on chin with dental gum injury above the front teeth as well as occipital right. Heart and lungs were normal. Abdomen was soft. Bowel sounds were lively and bowel content was very soft on palpation. The subject showed no signs of hepatosplenomegaly. Neurological examination was normal. Laboratory examination revealed signs of inflammation (white blood cell count of 11300/ul, which further increased to 20000/ul with shift of differential blood count towards left with band neutrophil percentage of 6 % and segmented neutrophil percentage of 38 %; as well as increased C-reactive protein of 11.4 mg/l, which further increased to 35.6 mg/l). Stool examination showed no rotaviral antigen. Blood culture was sterile. In hospital, the subject showed experienced diarrhea with bloody stools and further episodes of vomiting. On 27 February 2007 an abdominal ultrasound scan was performed and showed ileocolic intussusception in the right epigastric region with ileus and distinct ascites. Small intestine resection was performed on 27 February 2007. Subsequent to the surgery the subject''s symptoms improved. Abdominal ultrasound scan, performed on 02 March 2007, was normal. Post surgery, on 28 February 2007, the subject experienced obstructive bronchitis. Obstructive bronchitis resolved on treatment with Atrovent and Sultanol, and did not recur even after discontinuation of treatment with ipratropium bromide. After eight days, on 05 March 2007, the subject was discharged from the hospital in a good general condition. At that time he was treated with Perenterol. Follow-up information was received on 09 February 2009 from the reporting physician (not the vaccinating physician): According to this report, on 30 December 2006 the subject had received the first dose of ROTARIX. The reporting physician was unsure about the date, which was Saturday. On 07 February 2007 the subject had received the second dose of ROTARIX. Nineteen days later the subject had been hospitalized for intussusception. The treating physician considered that ileocolic intussusception with ileus and ascites was unlikely related to vaccination with ROTARIX. The reporting physician did neither specify the causal relationship of the diagnosed events (including bruise of head, gastroenteritis and obstructive bronchitis to vaccination with ROTARIX, nor the causal relationship of any of the other observed events and symptoms to vaccination with ROTARIX.


VAERS ID: 340281 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:2008-10-27
Onset:2008-12-24
   Days after vaccination:58
Submitted: 2009-02-20
   Days after onset:58
Entered: 2009-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal pain, Blood potassium increased, Blood sodium normal, Gastrointestinal sounds abnormal, Haematochezia, Haemoglobin normal, Hyperaemia, Intussusception, Irritability, Laparotomy, Lymphadenopathy, Neutrophil percentage decreased, Platelet count normal, Prothrombin time normal, Pyrexia, Vomiting, White blood cell count increased, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Chronic kidney disease (broad), Tumour lysis syndrome (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, Dec2006, See text; Hemoglobin, 26Dec2008, 10.2g/dL; Neutrophil percentage, 26Dec2008, 44%; Platelet count, 26Dec2008, 219000/mm3; Potassium, 27Dec2008, 5.6mEq; Potassium, 28Dec2008, 5mEq; Prothrombin time, 26Dec2008, 11.3Seconds; Sodium, 27Dec2008, 135mEq; Sodium, 28Dec2008, 136mEq; White blood cell count, 26Dec2008, 13500/mm3
CDC Split Type: B0558773A

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 had no relevant medical history or allergy. The subject had no concomitant medication. On 27 October 2008, the subject received the 1st dose of ROTARIX (oral, lot number not provided). On 24 December 2008, 58 days after vaccination with the 1st dose of ROTARIX, the subject experienced vomiting, bloody stools, abdominal pain and fever. On 25 December 2008, the subject was admitted at ER; physical exam reported irritability, fever, cervical adenopathy, hyperemic pharynx, abdominal pain and increased bowel sounds. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). Lab tests were performed on 26 December 2008 and showed the following: Hemoglobin: 10.2 g/dL; Platelets: 219000/mm3; Prothrombin time: 11.3 Seconds; Leucocytes: 13500/mm3. Abdominal X-ray was performed and showed distention loops and gas/liquid levels. Intussusception was suspected and confirmed by laparotomy on 26 December 2008; Ileocecal intussusception was found and reduced by taxis without complications. Lab tests were performed on 27 December 2008 and showed the following: Potassium: 5.6 mEq; Sodium: 135. Lab tests were performed on 28 December 2008 and showed the following: Potassium: 5 mEq; Sodium: 136. The subject was treated with AMOXICILLIN, trimethoprim + sulfamethoxazol, Metamizol, Ampicillin, metoclopramide and paracetamol. On 29 December 2008, the events were resolved. The vaccination course with ROTARIX was discontinued because of the intussusception. The physician considered the events were unrelated to vaccination with ROTARIX.


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