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Found 568 cases where Vaccine is RV1 and Symptom is Intussusception and Appearance Date from '2008-02-01' to '2014-12-31'

Case Details

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VAERS ID: 322228 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-01-10
Onset:2008-01-14
   Days after vaccination:4
Submitted: 2008-08-14
   Days after onset:212
Entered: 2008-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / IM
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal pain, Appendicectomy, Barium double contrast, Haematemesis, Haematochezia, Inappropriate schedule of drug administration, Intussusception, Irritability, Mucous stools, Surgery, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), 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), Medication errors (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? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0532764A

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 history or family history of intussusception or bowel abnormalities. She had no congenital intestinal malformation or other gastrointestinal malformation and dysfunction. Previous and/or concurrent vaccination included the 1st dose of combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (manufacturer unspecified; intramuscular0 given on 10 January 2008; 1st dose of hepatitis B vaccine recombinant (manufacturer unspecified; intramuscular) given on 10 January 2008; 1st dose of pneumococcal vaccine, unspecified (manufacturer unspecified; intramuscular) given on 10 January 2008 and a unique dose of tuberculosis vaccine (manufacturer unspecified; intradermal) given on 27 September 2007. On 10 January 2008, the subject received the 1st dose of ROTARIX (oral, lot number not provided). On 14 January 2008, 4 days after vaccination with the 1st dose of ROTARIX, the subject was admitted into the emergency room with one day of evolution with abdominal pain, a colic type, irritability, 2 times vomiting with gastric content and 4 evacuations with mucus and the last two with blood (seems like black currant jelly), he was giving initial diagnosis of intestinal intussusception. An abdominal X-ray was performed and was sentinel loop and abdominal distension and had it too clinically. Plain abdominal radiograph showed fluid levels and dilated bowel loops. Plain abdominal radiography did not show a visible intussusception or soft tissue mass. Invagination of the intestine was not demonstrated by air or liquid contrast enema. Plain abdominal radiograph did not show non-specific abnormalities. Abdominal ultrasound and abdominal CT were not performed. The physician considered the events were clinically significant (or requiring intervention). On 14 January 2008 intervention was decided; finding intussusception without referring the type, which remits by taxis without needing intestinal resection, no complications. An appendectomy was performed. The subject had good response and favorable evolution and he was discharged on 21 January 2008. On 21 January 2008, intussusception resolved. The physician considered the events were possibly related to vaccination with ROTARIX. Next vaccinations included the 2nd dose of ROTARIX (GlaxoSmithKline), the 2nd dose of combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (manufacturer unspecified; intramuscular) given on 10 March 2008; the 2nd dose of hepatitis B vaccine recombinant (manufacturer unspecified; intramuscular) given on 10 March 2008 and the 2nd dose of pneumococcal vaccine, unspecified (manufacturer unspecified; intramuscular) given on 10 March 2008.


VAERS ID: 322488 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-06-30
Onset:2008-07-30
   Days after vaccination:30
Submitted: 2008-08-18
   Days after onset:19
Entered: 2008-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal pain, Activated partial thromboplastin time shortened, Blood group O, Gastrointestinal hypomotility, Gastrointestinal pain, Haematochezia, Haematocrit decreased, Haemoglobin normal, Intestinal anastomosis, Intestinal resection, Intussusception, Irritability, Pharyngeal erythema, Platelet count increased, Prothrombin time prolonged, Rhesus antibodies positive, Vomiting, White blood cell count increased, X-ray abnormal
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Haemolytic disorders (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (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), 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)

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, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 30Jul2008, see text; Blood group O, 30Jul2008, Orh+; Hematocrit, 30Jul2008, 32.1%; Hemoglobin, 30Jul2008, 10.4g/dl; Leukocyte count NOS, 30Jul2008, 32000/mm3; Partial prothrombin time, 30Jul2008, 25.1sec; Platelet count, 30Jul2008, 637000/mm3; Prothrombin time, 30Jul2008, 12.8sec
CDC Split Type: B0533056A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of ileo-colic intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was on no other medication and had no relevant medical history or allergy. Previous vaccination included ROTARIX (GlaxoSmithKline, oral) given on 29 April 2008. On 30 June 2008, the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 30 July 2008, 30 days after vaccination with ROTARIX, the subject was taken to emergency room with irritability. The physical exam showed hyperemic pharynx, pain in colonic zone and decreased gastrointestinal peristalsis. During hospitalization, the subject experienced gastric vomiting, abdominal pain right side and hematochezia. Abdominal X-ray was performed on 30 July and showed fix loop in right side, air-fluid-levels in iliac right side and lack of air in rectal ampulla. Surgery was done on 30 July 2008 and showed ileo-colic intussusception from appendix, ileo-caecal valve to colonic spleeny angle with vascular compromise of ileon. Resection with term-to-term anastomosis was done without complications. The subject had good clinical evolution. Laboratory tests were performed on 30 July and showed the following results: Hemoglobin: 10.4 g/dl; Hematocrit: 32.1%; Platelet count: 637 000/mm3; Leukocyte count: 32 000/mm3; Blood Group: O Rh+; PT: 12.8 sec; PTT: 25.1 sec. The subject was treated with paracetamol. On 6 August 2008, the subject was discharged. The physician considered the events were possibly related to vaccination with ROTARIX.


VAERS ID: 322489 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:2007-11-22
Onset:2008-01-03
   Days after vaccination:42
Submitted: 2008-08-18
   Days after onset:227
Entered: 2008-08-18
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
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Enteritis, Inappropriate schedule of drug administration, Intussusception, Surgery
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (broad), Medication errors (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, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0533335A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history. Previous and/or concurrent vaccination included DTaP-IPV-HIB (manufacturer unspecified, intramuscular) given on 22 November 2007 and 22 January 2008; Hep B (manufacturer unspecified, intramuscular) given on 20 September 2007, 22 November 2007 and 22 March 2008; ROTARIX (GlaxoSmithKline, oral) given on 22 January 2007, pneumococcal vaccine (manufacturer unspecified, intramuscular) given on 22 November 2007 and 22 January 2008; tuberculosis vaccine (manufacturer unspecified, intradermal) given on 20 September 2007. On 22 November 2007, the subject received 1st dose of ROTARIX (1 ml, oral). Lot number not provided. On 3 January 2008, 42 days after vaccination with ROTARIX, the subject was taken to ER, with colicky abdominal pain and 2 evacuations without mucus or blood with initial diagnosis of acute enteritis. After evaluation, intestinal intussusception was diagnosed. The surgery was done on 3 January 2008 and showed ileo-colic intussusception resolved by taxis without resection and complication. The subject had good response and favorable evolution. The subject was hospitalized and the physician considered the events were clinically significant (or requiring intervention). The physician did not have any data about diagnostic procedure. No abdominal X-ray or ultrasound was performed. On 6 January 2008, the events were resolved by surgery and the patient was discharged. After the next vaccination with ROTARIX the events did not recur. The physician considered the events were possibly related to vaccination with ROTARIX.


VAERS ID: 322636 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2008-07-14
Onset:2008-07-17
   Days after vaccination:3
Submitted: 2008-08-19
   Days after onset:33
Entered: 2008-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Colectomy, Enema administration, Intestinal operation, Intussusception, Surgery
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
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: D0058386A

Write-up: This case was reported by an unknown physician via a regulatory authority and described the occurrence of invagination of intestine in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). It was unknown whether or not the subject experienced any adverse event post previous vaccination(s). On 14 July 2008 the subject received an unspecified dose of ROTARIX (0.5 ml, oral). Approximately three days post vaccination with ROTARIX, on 17 July 2008, the subject experienced invagination of intestine. The subject was hospitalised for an unknown period of time. The reporting physician considered that the event was life threatening. Treatment included hydrostatic disinvagination on 17 July 2008 without success. On 18 July 2008 the subject underwent bowel surgery. The reporting physician considered undesirable vaccination adverse reaction. At the time of reporting, on 08 August 2008, the events were resolved with the following sequelae (state post surgery). No further information will be available.


VAERS ID: 322638 (history)  
Form: Version 1.0  
Age: 0.1  
Gender: Female  
Location: Foreign  
Vaccinated:2007-12-12
Onset:2008-04-03
   Days after vaccination:113
Submitted: 2008-08-19
   Days after onset:138
Entered: 2008-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Appendicectomy, Gastric disorder, Haematochezia, Inappropriate schedule of drug administration, Intussusception, Surgery, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Medication errors (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? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0533447A

Write-up: This case was reported by a physician and described the occurrence of ileo-ceco-colic intussusception in a 5-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history. Previous and/or concurrent vaccination included DTPa-IPV-HIB (manufacturer unspecified, intramuscular) given on 12 December 2007, 15 February 2008 and 15 April 2008; pneumococcal vaccine, unspecified (manufacturer unspecified, intramuscular) given on 12 December 2007 and 15 February 2008; tuberculosis vaccine (manufacturer unspecified, intradermal) given on 25 October 2007. On 12 December 2007, the subject received 1st dose of ROTARIX (oral). Lot number not provided. On 3 April 2008, 113 days after vaccination with ROTARIX, the subject was taken to ER with gastric intolerance with 5 episodes of vomiting and 2 bloody stools like black currant jelly. The diagnosis was done clinically. Surgery was performed on 3 April 2008 and showed ileo-ceco-colic intussusception resolved by taxis with prophylactic appendectomy without resection and complication. The patient had good response and was discharged on 6 April 2008. No abdominal x-ray, ultrasound or scan was performed. The physician considered the events were clinically significant (or requiring intervention). On 6 April 2008, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 322639 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:2008-02-05
Onset:2008-04-01
   Days after vaccination:56
Submitted: 2008-08-19
   Days after onset:140
Entered: 2008-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Appendicectomy, Gastrointestinal necrosis, Haematochezia, Intestinal anastomosis, Intestinal obstruction, Intussusception, Oral intake reduced, Surgery, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (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: Abdominal X-ray, 03Apr2008, abnormal
CDC Split Type: B0533443A

Write-up: This case was reported by a physician and described the occurrence of intussusception of intestine in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included DTPa-IPV-HIB; manufacturer unspecified; intramuscular given on 25 February 2008; hepatitis B vaccine recombinant; manufacturer unspecified; intramuscular given on 8 December 2007 and 25 February 2008; pneumococcal vaccine, unspecified (manufacturer unspecified; intramuscular given on 25 February 2008; tuberculosis vaccine; non-GSK manufacturer; intradermal given on 3 December 2007. On 5 February 2008 the subject received 1st dose of ROTARIX (oral). On 03 April 2008, 2 months after vaccination with ROTARIX, the subject was in the emergency room due to 1 day of evolution of gastric vomiting (8 times), intolerance to oral intake and 2 bloody stools (seemed like black current jelly stools). Relevant test include abdominal x-ray finding air-fluid levels and data of intestinal obstruction. The same day the subject underwent a surgery in which it was found ileococecal intussusception with necrosis ileum (8 cm) and ascending colon (15 cm). A prophylactic appendectomy was also done and termini terminal union without complications. On 10 April 2008, 7 days after the subject presented a good evolution, therefore he was discharged. The subject was treated with cefotaxime, amikacin and metronidazole. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). On 10 April 2008, the events were resolved. The physician considered the events were possibly related to vaccination with ROTARIX. On 25 April 2008 the subject was revaccinated with the 2nd dose of ROTARIX (oral), 2nd dose of DTPa-IPV-HIB; manufacturer unspecified; intramuscular and 2nd dose of pneumococcal vaccine, unspecified; manufacturer unspecified.


VAERS ID: 322722 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Foreign  
Vaccinated:2008-07-01
Onset:2008-07-05
   Days after vaccination:4
Submitted: 2008-08-20
   Days after onset:46
Entered: 2008-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Barium enema, Body temperature increased, Dehydration, Gastrointestinal sounds abnormal, Haematochezia, Haemoglobin decreased, Intestinal perforation, Intestinal resection, Intussusception, Pallor, Pyrexia, Surgery, Ultrasound abdomen abnormal
SMQs:, Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal perforation (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (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, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: thyroxine sodium
Current Illness: HEART MURMUR; HYPOTHYROIDISM
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature, 05Jul2008, 38.7Deg C; Hemoglobin, 05Jul2008, 9.9g/dl; Ultrasound abdomen, 05Jul2008, Obstructionunit
CDC Split Type: B0533379A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no allergy. Concurrent medical conditions included heart murmur and hypothyroidism. Concurrent medications included LEVOTYROXIN. On 1 July 2008, the subject received 1st dose of ROTARIX (oral), lot number not provided. On 5 July 2008, 4 days after vaccination with ROTARIX, the subject experienced bloody stools and fever (38.7 Deg C), leading to hospitalisation the same day. The physical examination showed dehydration, pallor, abdominal pain and absent bowel sounds. The laboratory test showed hemoglobin 9.9 g/dl. The abdominal ultrasound suggested an intestinal obstruction and the diagnosis of intussusception was made. Treatment with barium salt failed to resolve the intussusception. The surgery performed on 5 July 2008 revealed an ileocolic intussusception and 3 small bowel perforations which were repaired. A 20 cm ileocecal valvule resection was performed without complication. The subject was hospitalised for 8 days. On 12 July 2008, the subject was discharged from hospital in good clinical condition with a 3 days paracetamol treatment. At the time of reporting the events were resolved. The physician considered the events were almost certainly related to vaccination with ROTARIX.


VAERS ID: 322727 (history)  
Form: Version 1.0  
Age: 0.5  
Gender: Male  
Location: Foreign  
Vaccinated:2008-05-09
Onset:2008-07-19
   Days after vaccination:71
Submitted: 2008-08-20
   Days after onset:32
Entered: 2008-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Activated partial thromboplastin time, Barium enema, Barium enema abnormal, Gastrointestinal sounds abnormal, Haematochezia, Haematocrit normal, Haemoglobin normal, Intussusception, Irritability, Mucous stools, Oral intake reduced, Pallor, Pharyngeal erythema, Prothrombin time normal, Rectal haemorrhage, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (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), 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: Barium enema, 19Jul2008; Hematocrit, 19Jul2008, 36%; Hemoglobin, 19Jul2008, 11.8g/dl; Partial prothrombin time, 19Jul2008, 40sec; Prothrombin time, 19Jul2008, 12.3 sec
CDC Split Type: B0533477A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of ileo-ceco-colic 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 or allergy. On 9 May 2008, the subject received 1st dose of ROTARIX (oral). Lot number not provided. On 19 July 2008, 71 days after vaccination with ROTARIX, the subject started with oral intake reduced, abdominal colic, bloody fresh stools, vomiting and irritability. He was taken to ER on 19 July 2008 and at physical exam showed pallor, hyperemic pharynx, currant jelly stools, abdomen with dance sign, bowel sounds decreased, and rectal tact with presence of blood. Barite enema was performed on 19 July 2008; ileo-ceco-colic intussusception was found and reduced in the first intent with success. Any complication was reported. The subject was hospitalized and discharged in good clinical conditions on 22 July 2008. Laboratory tests were performed on 19 July 2008 and showed the following results: Hemoglobin: 11.8 g/dl; Hematocrit: 36 ; PT: 12.3 sec; PTT: 40 sec. No abdominal x-ray was reported in the clinical file. On 22 July 2008, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 322728 (history)  
Form: Version 1.0  
Age: 0.5  
Gender: Male  
Location: Foreign  
Vaccinated:2008-04-16
Onset:2008-07-08
   Days after vaccination:83
Submitted: 2008-08-20
   Days after onset:43
Entered: 2008-08-20
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, Activated partial thromboplastin time, Blood glucose increased, Blood potassium decreased, Blood sodium decreased, Enema administration, Gastrointestinal sounds abnormal, Haematochezia, Haematocrit normal, Haemoglobin normal, Intestinal congestion, Intestinal functional disorder, Intussusception, Neutrophil count, Oral intake reduced, Platelet count normal, Prothrombin time shortened, Rectal haemorrhage, Urine analysis normal, Vomiting, White blood cell count, X-ray abnormal, pH urine normal
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), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Ischaemic colitis (broad), Chronic kidney disease (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, 22 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 09Jul2008, abnormal; Blood glucose, 09Jul2008, 93mg/dl; Hematocrit, 09Jul2008, 37.7%; Hemoglobin, 09Jul2008, 9600/mm3; Neutrophils, 09Jul2008, 63%; Partial prothrombin time, 09Jul2008, 27.5sec; Platelet count, 09Jul2008, 384000/mm3; Potassium, 09Jul2008, 4mEq/l; Prothrombin time, 09Jul2008, 10.8sec; Urinary analysis, 09Jul2008, negative; pH urine, 09Jul2008, 6
CDC Split Type: B0533485A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of ileo-colic intussusception in a 8-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was on no other medication and had no relevant medical history or allergy. Previous and/or concurrent vaccination included ROTARIX (GlaxoSmithKline, oral) given on 15 February 2008. On 16 April 2008; the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 8 July 2008, 83 days after vaccination with ROTARIX, the subject started with abdominal pain, vomiting and poor oral intake. On 9 July 2008, he was taken to ER. At physical exam, he experienced abdominal pain to palpation, abdominal mass in transverse colon, bowel sounds decreased, bloody stools and rectal tract with blood and empty rectal ampulla. On 9 July 2008, abdominal x-ray was performed and showed lack of air in intestine, right side, lack of air in distal zone and dilated bowel loop. On 9 July 2008, pneumo-enema was done and showed invagination to transverse colon which was reduced in the first intent with success without complication. The subject was hospitalised and discharged in good clinical conditions on 31 July 2008. Laboratory tests were performed on 9 July 2008 and showed the following results: Hemoglobin: 13 g/dl; Hematocrit: 37.7%; Platelets: 384 000/mm3; Leukocytes: 9600/mm3; Neutrophils: 63%; PT: 10.8 sec; PTT: 27.5 sec; Glucose: 93 mg/dl; Sodium: 131 mEq/l; Potassium: 4 mEq/l; Urinary pH: 6; Urinary exam: leukocytes negative, bacteria negative, nitrites negative. The subject was treated with amikacin, metronadizole, ranitidine hydrochloride and METAMIZOLE. On 13 July 2008, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 322729 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Male  
Location: Foreign  
Vaccinated:2008-04-16
Onset:2008-07-09
   Days after vaccination:84
Submitted: 2008-08-20
   Days after onset:42
Entered: 2008-08-20
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 distension, Abdominal mass, Abdominal pain, Anorexia, Asthenia, Dehydration, Enema administration, Gastrointestinal sounds abnormal, Intussusception, Mucous stools, Pallor, Pharyngeal erythema, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (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, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 10Jul2008, see text unit
CDC Split Type: B0533591A

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). Previous and/or concurrent vaccination included DTPa-IPV-HIB; manufacturer unspecified; intramuscular given on 9 June 2008; hepatitis B vaccine recombinant: manufacturer unspecified; intramuscular given on 9 June 2008; and ROTARIX (GlaxoSmithKline, oral) given on 11 February 2008. Previously the subject was healthy. On 16 April 2008 the subject received 2nd dose of ROTARIX (oral). On 9 July 2008, 84 days after vaccination with ROTARIX, the subject experienced abdominal distension, hyporexia, vomiting (4 times) and current jelly stools. On 19 July 2008 the subject was admitted and physical examination reported asthenia, adynamia, pallor, dehydration, hyperemic pharynx, abdominal sausage shaped mass, abdominal distension, absence of bowel sound and generalized abdominal pain. Relevant test included abdominal x-ray which showed distended loops, lack of distal air and bad air distribution. The diagnosis of intussusception was done and it was resolved by air enema without complications. After full recovery the subject was discharged on 13 July 2008 in good conditions. The subject was hospitalised for 4 days. The subject was treated with enema, metronidazole, amikacin and Ranitidine. The physician considered the events were unrelated to vaccination with ROTARIX.


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