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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: 320950 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-05-14
Onset:2008-07-04
   Days after vaccination:51
Submitted: 2008-07-31
   Days after onset:27
Entered: 2008-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Anorexia, Appendicectomy, Decreased activity, Dehydration, Diarrhoea, Gastrointestinal hypomotility, Haematochezia, Haematocrit decreased, Haemoglobin decreased, Intussusception, Platelet count increased, Prothrombin time prolonged, Surgery
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Gastro Esophageal Reflux
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Hematocrit, 07Jul2008, 35%; Hemoglobin, 07Jul2008, 12.3g/dl; Partial prothrombin time, 07Jul2008 51sec; Platelet count, 07Jul2008, 531000/mm3; Prothrombin time, 07Jul2008, 11sec
CDC Split Type: B0530958A

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 male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent medical conditions included gastro esophageal reflux. Previous vaccination included ROTARIX (GlaxoSmithKline, oral) given on 19 March 2008. On 14 May 2008, the subject received 2nd dose of ROTARIX (oral, lot number not provided). On 4 July 2008, 51 days after vaccination with ROTARIX, the subject experienced intussusception but there was no more information in the clinical chart. On 6 July 2008, 53 days after vaccination with ROTARIX, the subject was admitted at emergency room with diarrhea, hypoactivity, hyporexia, dehydration and decreased gastrointestinal peristalsis. 12 hours later, the patient showed bloody stools and rectal tact with expulsion of abundant blood. The subject was hospitalized and surgery was done on 7 July 2008. Intestinal invagination was corroborated and corrected by taxis with appendectomy, without complication. The patient was discharged in good clinical conditions on 9 July 2008. Laboratory test were performed on 7 July 2008 and showed the following results: Hemoglobin: 12.3 g/dl; Hematocrit: 35%; Platelets: 531000/mm3; PT: 11sec; PTT: 51 sec. The subject was treated with AMIKACINE, RANITIDINE, METAMIZOLE and CISAPRIDE. On 9 July 2008, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 322072 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2008-03-12
Onset:2008-05-11
   Days after vaccination:60
Submitted: 2008-08-13
   Days after onset:94
Entered: 2008-08-13
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 chloride normal, Dehydration, Diarrhoea, Gastrointestinal hypermotility, Haematocrit normal, Haemoglobin normal, Intussusception, Irritability, Lymphocyte percentage increased, Nausea, Neutrophil percentage decreased, Pallor, Peristalsis visible, Pharyngeal erythema, Platelet count increased, Pyrexia, Surgery, Vomiting, White blood cell count decreased, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 14May2008, see text; Chloride, 14May2008, 94mEq/l; Hematocrit, 14May2008, 35%; Hemoglobin, 14May2008, 11g/dl; Leukocyte count NOS, 14May2008, 7530/mm3; Lymphocytes, 14May2008, 57%; Neutrophils, 14May2008, 29%; Platelet count, 14May2008, 527000/mm3
CDC Split Type: B0532192A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of ileo-ileo-caeco-colic intussusception in a 6-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was on no other medication and had no relevant medical history and no allergy. Previous and/or concurrent vaccination included ROTARIX (GlaxoSmithKline, oral) given on 17 January 2008. On 12 March 2008, the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 11 May 2008, 60 days after vaccination with ROTARIX, the subject experienced nausea, vomiting, fever and one liquid stool. She was taken to emergency room with pallor, dehydration, hyperemic pharynx and abdominal zone with increased peristalsis. 15 hours later, the patient showed evidence of abdominal distention, irritability, more vomiting and diarrhea. Abdominal x-ray performed on 14 May 2008 showed liquid air levels and lack of distal air. The subject was hospitalized and surgery was done on 15 May 2008. Ileo-ileo-caeco-colic intussusception was found on descendent colon resolved by taxis and appendectomy without complication. The subject showed good evolution. Laboratory tests were performed on 14 May 2008 and showed the following results: Hemoglobin: 11 g/dl; Hematocrit: 35%; Leukocytes: 7530 /mm3; Neutrophils: 29%; Platelets: 527000 /mm3; Lymphocytes: 57%; Chloride: 94 mEq/l. The subject was treated with ranitidine, metoclopramide, paracetamol, cefotaxime, metronidazole, amikacin, dipyrone and ampicillin trihydrate. On 21 May 2008, the events were resolved and the subject was discharged. The physician considered the events were unrelated to vaccination with ROTARIX. No additional information expected; the case has been closed.


VAERS ID: 322073 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-03-07
Onset:2008-03-13
   Days after vaccination:6
Submitted: 2008-08-13
   Days after onset:153
Entered: 2008-08-13
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
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Appendicectomy, Barium double contrast, Conjunctivitis, Enema administration, Familial risk factor, Haematochezia, Intussusception, Irritability, Pyrexia, Rhinorrhoea, Surgery, X-ray abnormal
SMQs:, Severe cutaneous adverse reactions (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Ischaemic colitis (broad), Conjunctival disorders (narrow), Ocular infections (broad), Hypersensitivity (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? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 13Mar2008, abnormal
CDC Split Type: B0532220A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had genetic antecedents of cardiopathy. Previous and/or concurrent vaccination included DTaP-IPV-HIB (manufacturer unspecified, intramuscular) given on 7 March 2008; Hep B (manufacturer unspecified, intramuscular) given on 19 December 2007 and 7 March 2008; pneumococcal vaccine (manufacturer unspecified, intramuscular) given on 7 March 2008; tuberculosis vaccine (manufacturer unspecified, intradermal) given on 19 December 2007. On 7 March 2008, the subject received 1st dose of ROTARIX (oral). Lot number not provided. On 13 March 2008, 6 days after vaccination with ROTARIX, the subject was taken to ER with rhinorrhea, conjunctival secretions, fever, irritability and 2 bloody stools like black current jelly. Intussusception was suspected. The patient was hospitalized. On 14 March 2008, ileo-ileo-cecolic intussusception was diagnosed with resolved by taxis with appendectomy without resection and complication. The subject had good response and favorable evolution. The physician considered the events were clinically significant or requiring intervention). Abdominal X-ray was performed and showed fluid levels and dilated bowel loops. Air or Liquid contrast enema did not show visible intussusception or soft tissue mass, or invagination of intestine, or specific abnormalities. On 26 March 2008, the events were resolved by surgery and the patient was discharged. The physician considered the events were possibly related to vaccination with ROTARIX.


VAERS ID: 322074 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:2008-03-07
Onset:2008-05-04
   Days after vaccination:58
Submitted: 2008-08-13
   Days after onset:101
Entered: 2008-08-13
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, Barium double contrast, Grand mal convulsion, Haematochezia, Intussusception, Melaena, Mucous stools, Pyrexia, Surgery, Vomiting, X-ray normal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Convulsions (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Generalised convulsive seizures following immunisation (narrow), 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? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0532328A

Write-up: This case was reported by a physician and described the occurrence of ileo-caeco-colic intussusception in an 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history. Previous vaccination included hepatitis B vaccine recombinant (manufacturer unspecified, intramuscular) ; tuberculosis vaccine (manufacturer unspecified, intradermal) given on 29 December 2007. On 7 March 2008, the subject received 1st dose of ROTARIX (oral). Lot number not provided; On 4 May 2008, 58 days after vaccination with ROTARIX, the subject was taken to emergency room and started with abdominal pain, colic, 8 episodes of vomiting, 2 bloody stools like black currant jelly, fever and 1 tonic-clonic seizure. The initial diagnosis was gastroenteritis but the occurrence of bloody stools corroborated the diagnosis of intussusception which was confirmed by abdominal x-ray. The surgery was done on 4 May 2008. Ileo-caeco-colic intussusception was resolved by taxis without intestinal resection and complication. The patient had good response and favorable evolution. Abdominal radiography performed did not show abnormalities, visible intussusception or soft tissue mass, fluid levels and dilated bowel loops. Air or liquid contrast Enema performed did not demonstrate invagination of the intestine. Abdominal ultrasound was not done in diagnostic procedures. The physician considered the events were clinically significant (or requiring intervention). On 7 May 2008, the events were resolved and the patient was discharged. The physician considered the events were unrelated to vaccination with ROTARIX. Additional information has been requested.


VAERS ID: 322076 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2008-03-18
Onset:2008-04-06
   Days after vaccination:19
Submitted: 2008-08-13
   Days after onset:129
Entered: 2008-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Appendicectomy, Dyspnoea, Enema administration, Febrile convulsion, Haematochezia, Intestinal resection, Intussusception, Necrosis, Pharyngolaryngeal pain, Pyrexia, Rhinorrhoea, Surgery, X-ray abnormal
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ischaemic colitis (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 06Apr2008, see text
CDC Split Type: B0532333A

Write-up: This case was reported by a physician 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. Previous and/or concurrent vaccination included DTaP-IPV-HIB (manufacturer unspecified, intramuscular) given on 15 May 2008; DTaP-Hep B-IPV (manufacturer unspecified, intramuscular) given on 15 February 2008; Hep B (manufacturer unspecified, intramuscular) given on 15 November 2007 and 15 January 2008; ROTARIX (GlaxoSmithKline, oral) given on 15 January 2008; pneumococcal vaccine, unspecified (manufacturer unspecified, intramuscular) given on 15 February 2008 and 15 May 2008; tuberculosis vaccine (manufacturer unspecified, intradermal) given on 15 November 2007. On 18 March 2008, the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 6 April 2008, 19 days after vaccination with ROTARIX, the subject was taken to emergency room with pharyngeal pain, rhinorrhea, mild respiratory difficulty, fever and febrile seizures. The subject experienced bloody stools like black currant jelly giving the diagnosis of intestinal intussusception which was confirmed by abdominal x-ray. The surgery was done on 7 April 2008 and showed ileo-cecal intussusception in the last portion of ileon with 5 cm of necrosis. A terminal resection with a prophylactic appendectomy was performed without complication. The patient had good response and favorable evolution. Abdominal radiography performed showed fluid levels and dilated bowel loops but the x-ray did not show abnormalities, visible intussusception or soft tissue mass. Air or liquid contrast Enema performed did not demonstrate invagination of the intestine. Abdominal ultrasound was not done in diagnostic procedures. The physician considered the events were clinically significant (or requiring intervention). On 12 April 2008, the events were resolved and the patient was discharged. The physician considered the events were unrelated to vaccination with ROTARIX. No further information expected therefore the case has been closed.


VAERS ID: 322078 (history)  
Form: Version 1.0  
Age: 0.7  
Gender: Female  
Location: Foreign  
Vaccinated:2007-12-14
Onset:2008-04-01
   Days after vaccination:109
Submitted: 2008-08-13
   Days after onset:134
Entered: 2008-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 2 UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Anaemia, Dehydration, Haematochezia, Ileostomy, Inappropriate schedule of drug administration, Intestinal resection, Intussusception, Necrosis, Oral intake reduced, Pyrexia, Surgery, Transfusion, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Medication errors (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 04Apr2008, abnormal
CDC Split Type: B0532361A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 11-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included DTaP-IPV-HIB; manufacturer unspecified; intramuscular given on 22 October 2007, 14 December 2007 and 18 February 2008; Hep B; manufacturer unspecified; intramuscular given on 15 August 2007, 22 October 2007 and 18 February 2008; Flu; manufacturer unspecified; intramuscular given on 18 February 2008; ROTARIX; GlaxoSmithKline; oral given on 22 October 2007; pneumococcal vaccine, unspecified; manufacturer unspecified; intramuscular given on 22 October 2007 and 14 December 2007; tuberculosis vaccine; non-GSK manufacturer; intradermal given on 15 August 2007. On 14 December 2007 the subject received 2nd dose of ROTARIX (oral). On April 2008, 3 months after vaccination with ROTARIX, the subject was brought to the emergency room due to 4 days of evolution with abundant vomiting, intolerance to oral intake, non assess fever and 2 days of evolution of bloody stools (like black currant jelly). The subject was treated with albendazole, BUTILHIOSCINE. After being admitted to the emergency room with moderate dehydration the subject was diagnosed with intestinal intussusception. Relevant test results included abdominal x-ray which showed fluid levels and dilated bowel loops. On 05 April 2008 the subject underwent a surgery in which intussusception ileocecal and ileoleal was found, in the last portion of the ileo it was found 5 cm of necrosis and later other 10 cm. Therefore a resection was performed for the last portion of ileus, cecal and xyphoid. Ileostomy was done with out complications. The subject presented favorable evolution but required jugular venodissection and packed red blood cell due to anemia. On 06 May 2008 the subject was discharged. The subject was hospitalized and the physician considered the events were clinically significant (or requiring intervention). At the time of reporting the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 322079 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Foreign  
Vaccinated:2007-12-07
Onset:2007-12-22
   Days after vaccination:15
Submitted: 2008-08-13
   Days after onset:234
Entered: 2008-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Apnoea, Dehydration, Gastrointestinal necrosis, Haematochezia, Intussusception, Oral intake reduced, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Respiratory failure (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray 22DEC2007 showed air fluid levels and dilated bowel loops
CDC Split Type: B0532385A

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. Previous and/or concurrent vaccination included combined DTAP, IPOL and HIB; manufacturer unspecified; intramuscular given on 17 December 2007; RECOMBIVAX HB; manufacturer unspecified; intramuscular given on 13 October 2007 and 17 December 2007; PREVNAR, unspecified; manufacturer unspecified; intramuscular given on 17 December 2007; tuberculosis vaccine; non-GSK manufacturer; intradermal given on 13 October 2007. On 7 December 2007 the subject received 1st dose of ROTARIX (oral). On 22 December 2007, 15 days after vaccination with ROTARIX, the subject was brought to the emergency room due to 2 days of evolution with abundant vomiting, intolerance to oral intake, non assess fever and bloody stools (like black currant jelly). The subject was admitted with severe dehydration. Relevant test included abdominal x-ray which showed air fluid levels and dilated loops. The same day the subject underwent a surgery in which ileocecal intussusception was confirmed. In the last portion of the ileo and before the cecal and first portion of colon 5 cm of necrosis was found. A resection was performed in the last portion of ileum, cecal and xyphoid, performed a terminal union without complication. On 01 January 2008 the subject presented apnea and he was intubated for a few hours. Two days after the subject presented a favorable evolution. On 05 January 2008 the subject was discharged. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). On 6 January 2008, the events were resolved. The physician considered the events were possibly related to vaccination with ROTARIX. On 18 February 2008 the subject received the 2nd dose of ROTARIX. No adverse event has been reported.


VAERS ID: 322082 (history)  
Form: Version 1.0  
Age: 0.33  
Gender: Female  
Location: Foreign  
Vaccinated:2008-03-13
Onset:2008-03-13
   Days after vaccination:0
Submitted: 2008-08-13
   Days after onset:153
Entered: 2008-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Appendicectomy, Food intolerance, Haematochezia, Ileus, Intussusception, Pyrexia, Surgery, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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? 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: B0532576A

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. On 13 March 2008 the subject received 1st dose of ROTARIX (oral). On 20 March 2008, 7 days after vaccination with ROTARIX, the subject was into the emergency room due to 4 days of evolution with abundant vomiting, intolerance to oral intake, non assess fever and 2 days of evolution with bloody stools (like black currant jelly stools). The subject was treated with metronidazole and gentamicin. Intussusception was clinically diagnosed, no x-ray nor ultrasound was done. The same day the subject underwent a surgery where ileocolic intussusception was found. The event was resolved by taxis. Prophylactic appendectomy was done without complications. The subject had a regular evolution, she had no intestinal activity, ventilation worsened and the subject required transfusion due to anemia. She presented hemorrhage from the upper digestive tube and resisting fever. It was decided to transfer her to a bigger hospital due to ileus and the worsening of medical conditions. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). At the time of reporting the events were worse. The reporter did not have more data to give a follow up report and he did not know if the subject improved. The physician considered the events were possibly related to vaccination with ROTARIX.


VAERS ID: 322225 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:2008-01-18
Onset:2008-01-21
   Days after vaccination:3
Submitted: 2008-08-14
   Days after onset:205
Entered: 2008-08-14
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: Dehydration, Faeces discoloured, Food intolerance, Inappropriate schedule of drug administration, Intestinal ischaemia, Intussusception, Laparotomy, Surgery, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Noninfectious diarrhoea (broad), Medication errors (narrow), 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: UNK
CDC Split Type: B0532063A

Write-up: This case was reported by a physician and described the occurrence of invagination of intestine in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no history of 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 DTaP-IPV-HIB (manufacturer unspecified; intramuscular) given on 18 January 2008; hepatitis B vaccine recombinant (manufacturer unspecified; intramuscular) given on 4 November 2007 and 18 January 2008; pneumococcal vaccine, unspecified (manufacturer unspecified; intramuscular) given on 18 January 2008; tuberculosis vaccine (manufacturer unspecified; intradermal) given on 4 November 2007. On 18 January 2008, the subject received the 1st dose of ROTARIX (oral, lot number not provided). On 21 January 2008, 3 days after vaccination with the 1st dose of ROTARIX, the subject experienced invagination of intestine. The subject started with alimentary vomiting and intolerance to PO with 30 hrs of evolution, she was treated with co-trimoxazole and metoclopramide. On 23 January 2008 at 13.00 hrs, the subject had diagnosis of moderate dehydration and was giving oral hydration. She came back for another consult on the same day at 15.35 hrs with stools that "seemed like black currant jelly"; hospitalization was required with the diagnosis of intestinal intussusception. Abdominal radiograph, abdominal ultrasound and abdominal CT were not performed. The physician considered the events were clinically significant (or requiring intervention). A close reduction surgery was performed on 23 January 2008 without complications by laparotomy finding ileo ileal and ileo colic invagination with data of intestinal ischemia that began to remit at the end of procedure. Intestinal resection was not required. On 23 January 2008, intestinal invagination resolved. The physician considered the events were possibly related to vaccination with ROTARIX. Physician didn''t have a favorable progress note or a surgery note after this data. No more information available.


VAERS ID: 322227 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Foreign  
Vaccinated:2007-11-18
Onset:2008-03-03
   Days after vaccination:106
Submitted: 2008-08-14
   Days after onset:163
Entered: 2008-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal pain, Inappropriate schedule of drug administration, Intussusception, Surgery, Ultrasound abdomen abnormal, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: Abdominal X-ray, Mar2008, See text; Ultrasound abdomen, Mar2008, see text
CDC Split Type: B0533050A

Write-up: This case was reported by a physician and described the occurrence of intestinal intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no history or family history of intussusception or bowel abnormalities. He had no congenital intestinal malformation or other gastrointestinal malformation and dysfunction. Previous and/or concurrent vaccination included DTaP, inactivated poliomyelitis and HIB vaccine (manufacturer unspecified; intramuscular) given on 18 November 2007 and 3 January 2008; hepatitis B recombinant (manufacturer unspecified; intramuscular) given on 12 September 2007; pneumococcal vaccine, unspecified (manufacturer unspecified; intramuscular) given on 18 November 2007 and 3 January 2008; tuberculosis vaccine (manufacturer unspecified; intradermal) given on 12 September 2007. On 18 November 2007, the subject received the 1st dose of ROTARIX (oral, lot number not provided). On 3 March 2008, 106 days after vaccination with the 1st dose of ROTARIX, the subject was admitted in the emergency room with abdominal pain, a colic type, 6 times vomiting with gastric content and two evacuations without mucus nor blood, with the initial diagnosis of intestinal intussusception. Abdominal ultrasound was performed with finding of loops distention; Abdominal X-Ray showed air-fluid levels. The subject had it clinically too. The physician considered the events were clinically significant (or requiring intervention). On 06 March 2008, surgical intervention was decided and was performed with the finding of intussusception without referring the type, which remitted by taxis without the need of intestinal resection, no complications. Patient had good response and favorable evolution and was discharged on 07 March 2008. On 7 March 2008, the events were resolved. The physician considered the events were possibly related to vaccination with ROTARIX.


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