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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: 322867 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2008-04-28
Onset:2008-04-30
   Days after vaccination:2
Submitted: 2008-08-21
   Days after onset:113
Entered: 2008-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR A2130 / 1 UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA573A / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Enema administration, Gastrointestinal necrosis, Haematochezia, Intestinal resection, Intussusception, Laparotomy, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), 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 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0533694A

Write-up: This case was reported by a regulatory authority (# FI-NAM-20080737) and described the occurrence of invagination of intestine in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline), PENTAVAC. On 28 April 2008, the subject received the 1st dose of ROTARIX (oral), the 1st dose of PENTAVAC (intramuscular, unknown injection site). On 30 April 2008, 2 days after vaccination with PENTAVAC and ROTARIX, the subject experienced vomiting and bloody faeces. On the third day after the vaccination the subject was admitted to the central hospital, where she was diagnosed with invagination. One day later the baby was operated. Reposition not successful with the colongraphy and only partly in the laparotomy. Terminal ileum had become necrotic. Resection of the intestine, 40 cm of the intestine was removed. Diagnosis: Invagination and necrosis of intestinal region ileocecalia. At the time of reporting the events were unresolved.


VAERS ID: 322868 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-03-04
Onset:2008-05-24
   Days after vaccination:81
Submitted: 2008-08-21
   Days after onset:89
Entered: 2008-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR - / 2 UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Appendicectomy, Haematochezia, Intestinal obstruction, Intussusception, Mucous stools, 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 (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, May2008, See Text
CDC Split Type: B0533717A

Write-up: This case was reported by a physician and described the occurrence of intussusception of intestine in a 7-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-IPV-Hib (manufacturer unspecified, intramuscular) given on 4 January 2008, 4 March 2008 and 5 May 2008; Hep B vaccine (manufacturer unspecified; intramuscular) given on 4 January 2008, 4 March 2008 and 5 May 2008; pneumococcal vaccine, ROTARIX (GlaxoSmithKline; oral) given on 4 January 2008; pneumococcal vaccine, unspecified (manufacturer unspecified; intramuscular) given on 4 January 2008; tuberculosis vaccine (manufacturer unspecified; intradermal) given on 30 October 2007. On 4 March 2008, the subject received the 2nd dose of ROTARIX (oral, lot number not provided). On 24 May 2008, 81 days after vaccination with the 2nd dose of ROTARIX, the subject was admitted into the emergency room due to 2 days of evolution with 6 times vomiting, gastric content, intolerance to PO and bloody stools (seemed like black currant jelly). Abdominal ultrasound and abdominal CT were not performed. Diagnosis was made by abdominal X-ray with the finding of air-fluid levels and data of intestinal obstruction and clinically. The physician considered the events were clinically significant (or requiring intervention). Surgery intervention was decided and was performed on 24 May 2008 with the finding ileococecal intussusception, which remitted by taxis (no resection); prophylactic appendectomy was performed without complications. Patient had good response after two days of evolution and was discharged on 26 May 2008. On 26 May 2008, the events were resolved. The physician considered the events were possibly related to vaccination with ROTARIX. Physician did not have more data to give a follow up report.


VAERS ID: 322869 (history)  
Form: Version 1.0  
Age: 0.6  
Gender: Male  
Location: Foreign  
Vaccinated:2007-10-25
Onset:2008-01-18
   Days after vaccination:85
Submitted: 2008-08-21
   Days after onset:215
Entered: 2008-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR - / UNK UN / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Appendicectomy, Haematochezia, Inappropriate schedule of drug administration, Intestinal obstruction, Intussusception, 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 (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, Jan2008, See text
CDC Split Type: B0533718A

Write-up: This case was reported by a physician and described the occurrence of intussusception of intestine in a 9-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 diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (manufacturer unspecified; intramuscular) given on 25 October 2007 and 18 July 2008; hepatitis B vaccine recombinant (manufacturer unspecified; intramuscular) given on 27 April 2007, 25 October 2007 and 18 July 2008; live attenuated rotavirus vaccine (GlaxoSmithKline; oral) given on 18 July 2007; pneumococcal vaccine, unspecified (manufacturer unspecified; intramuscular) given on 18 July 2007 and 25 October 2007; tuberculosis vaccine (manufacturer unspecified; intradermal) given on 27 April 2007. On 25 October 2007, the subject received the 2nd dose of ROTARIX (oral, lot number not provided). On 18 January 2008, 85 days after vaccination with the 2nd dose of ROTARIX, the subject was admitted into the emergency room due to 1 day of evolution with 5 times vomiting, gastric content, intolerance to PO and blood stools (seems like black currant jelly) without knowing number. Abdominal ultrasound and abdominal CT were not performed. Diagnostic method was abdominal X-ray with finding of air-fluid levels and data of intestinal obstruction and clinically. The physician considered the events were clinically significant (or requiring intervention). Surgery intervention was decided and was performed on 18 January 2008 with finding of ileococecal intussusception, which remitted by taxis (no resection); prophylactic appendectomy was performed without complications. Physician did not have more evolution notes after the intervention or discharge data; therefore no more data could be provided. At the time of reporting the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 324798 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:2008-07-15
Onset:2008-07-23
   Days after vaccination:8
Submitted: 2008-09-10
   Days after onset:49
Entered: 2008-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood test normal, Culture stool negative, Incorrect route of drug administration, Intussusception, Surgery, Vitello-intestinal duct remnant
SMQs:, Congenital, familial and genetic disorders (narrow), Gastrointestinal obstruction (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? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Vitamin D
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood test, Jul2008, Normalunit; Stool culture, Jul2008, Negativeunit
CDC Split Type: B0535298A

Write-up: This case was reported by a regulatory authority (foreign Regulatory Authority # DHH2301N2008-42013) and described the occurrence of intussusception in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKilne). Concurrent medications included Vitamin D. On 15 July 2008, the subject received 1st dose of ROTARIX intramuscular at an unknown injection site instead of orally. The lot number was not provided. On 23 July 2008, 8 days after vaccination with ROTARIX, the subject experienced ileo-ileal intussusception twice, followed by 2 episodes of ileo-colic intussusception within 6 days. The subject was hospitalised. The biology tests performed were normal. Stool culture was negative. No virology test was performed. The subject was treated with surgery. During the surgery, a Meckel''s diverticulum was found. On 30 July 2008, the events were resolved. The vaccination course with ROTARIX was discontinued.


VAERS ID: 326266 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Female  
Location: Foreign  
Vaccinated:2008-03-05
Onset:2008-08-03
   Days after vaccination:151
Submitted: 2008-09-26
   Days after onset:54
Entered: 2008-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal pain, Enema administration, Haematochezia, Intestinal obstruction, Intestinal resection, Intussusception, Surgery, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad)

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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, see text
CDC Split Type: B0538578A

Write-up: This case was reported by a physician and described the occurrence of ileocolic intussusception in a 10-month-old female subject who was vaccinated with ROTARIX, GlaxoSmithKline. The subject had no relevant medical history. Previous and/or concurrent vaccination included DTAP-IPOL-HIB (manufacturer unspecified, intramuscular) given on 3 December 2007, 5 February 2008 and 4 April 2008; HEP B (manufacturer unspecified, intramuscular) given on 24 September 2007, 3 December 2007 and 4 April 2008; tuberculosis vaccine (manufacturer unspecified, intradermal) given on 24 September 2007. On 5 March 2008, the subject received 1st dose of ROTARIX (1 ml, oral). Lot number not provided. On 3 August 2008, 5 months after vaccination with ROTARIX, the subject started with abdominal pain, vomiting, and bloody stools. The subject was hospitalized on 4 August 2008 with data of intestinal obstruction. The diagnosis of intussusception was confirmed by abdominal x-ray. The surgery was done on 5 August 2008. Ileocolic intussusception was resolved by intestinal resection of 40 cm without complication. The patient had good response and favorable evolution. The physician considered the events were life threatening and clinically significant (or requiring intervention). Abdominal radiography was performed and showed non-specific abnormalities, fluid levels and dilated bowel loops. The X-ray did not showed 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. On 18 August 2008, the events were resolved and the subject was discharged. The physician considered the events were possibly related to vaccination with ROTARIX.


VAERS ID: 326447 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Female  
Location: Foreign  
Vaccinated:2008-07-17
Onset:2008-08-01
   Days after vaccination:15
Submitted: 2008-09-29
   Days after onset:59
Entered: 2008-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal pain, Faeces discoloured, Haematochezia, Intestinal obstruction, Intussusception, Surgery, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (broad)

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, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 02Aug2008, ISUnit
CDC Split Type: B0538598A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 5-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included DTaP-IPV-HIB; manufacturer unspecified; intramuscular given on 8 May 2008 and 17 July 2008; Hep B; manufacturer unspecified; intramuscular given on 3 April 2008, 8 May 2008 and 17 July 2008; ROTARIX; GlaxoSmithKline; oral given on 8 May 2008; pneumococcal vaccine, unspecified; manufacturer unspecified; intramuscular given on 8 May 2008 and 17 July 2008; tuberculosis vaccine; manufacturer unspecified; intradermal given on 3 April 2008. On 17 July 2008 the subject received 2nd dose of ROTARIX (oral) lot number not provided. On 1 August 2008, 15 days after vaccination with ROTARIX, the subject experienced abdominal pain, bloody stools (like black current jelly) and continuing vomiting, clinically with data of intestinal intussusception. On 02 August 2008 relevant test included abdominal x-ray showing data of intestinal obstruction. The plain abdominal radiograph showed dilated bowel loops and non-specific abnormalities. The same day the subject underwent a surgery confirming ileoileocolic invagination which was resolved by taxis without complications. No bowel resection was needed. After surgery the subject had a good response. On 07 August 2008 the subject was discharged. The subject was hospitalized and the physician considered the events were life threatening and clinically significant (or requiring intervention). The physician considered the events were possibly related to vaccination with ROTARIX.


VAERS ID: 326448 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-09-13
Onset:2008-09-18
   Days after vaccination:5
Submitted: 2008-09-29
   Days after onset:11
Entered: 2008-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Crying, Haematochezia, Intussusception, Mucous stools, Surgery, Ultrasound scan abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Depression (excl suicide and self injury) (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Ultrasound scan, 18Sep2008, ISunit
CDC Split Type: B0538669A

Write-up: This case was reported by a physician and described the occurrence of ileocolic intussusception in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 13 September 2008 the subject received 1st dose of ROTARIX (unknown) lot number not provided. On 18 September 2008, 5 days after vaccination with ROTARIX, the subject presented severe vomiting enough to be hospitalized. The subject cried excessively and passed jelly currant stools. Relevant test included ultrasonography which showed ileocolic intussusception. The following day in the morning the subject underwent a surgery. The subject was hospitalised and the physician considered the events were life threatening and clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The physician considered the events were possibly related to vaccination with ROTARIX.


VAERS ID: 326588 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Male  
Location: Foreign  
Vaccinated:2008-06-17
Onset:2008-06-20
   Days after vaccination:3
Submitted: 2008-09-30
   Days after onset:102
Entered: 2008-09-30
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 / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal mass, Abdominal pain, Abdominal wound dehiscence, Haematochezia, Ileostomy, Intestinal obstruction, Intestinal perforation, Intestinal resection, Intussusception, Mucous stools, Surgery, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal perforation (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0538609A

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. Previous and/or concurrent vaccination included DTPA-HIB; manufacturer unspecified; intramuscular; given on 17 April 2008 and 17 June 2008; HEP B; manufacturer unspecified; intramuscularly; given on 30 January 2008 and 17 April 2008; ROTARIX; GlaxoSmithKline; oral given on 17 April 2008; PNEUMOVAX; manufacturer unspecified; intramuscular; given on 17 April 2008 and 17 June 2008; tuberculosis vaccine; manufacturer unspecified; intradermal; unknown deltoid given on 30 January 2008. On 17 June 2008, the subject received 2nd dose of ROTARIX (oral), lot number not provided. On 20 June 2008, 3 days after vaccination with ROTARIX, the subject experienced abdominal pain with bloody stools like current jelly stool and continuing vomiting. He was brought to hospital. At clinical examination, an abdominal mass was found. On 20 June 2008, surgery was performed and ileocolic intussusception was found and resolved by taxis without complication. However, the subject presented characteristics of intestinal obstruction and dehiscence of surgery injury, leading to 2nd surgery on 24 June 2008. The surgery revealed a 15 cm intestinal perforation of ileocecal valve, leading to intestinal resection and ileostomy. The subject was hospitalised for 14 days and the physician considered the events were life threatening and clinically significant (or requiring intervention). On 3 July 2008, the subject was discharged from hospital in good clinical condition. At the time of reporting the events were resolved with the following sequelae (intestinal resection and ileostomy). The physician considered the events were possibly related to vaccination with ROTARIX.


VAERS ID: 326697 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Male  
Location: Foreign  
Vaccinated:2008-02-18
Onset:2008-02-28
   Days after vaccination:10
Submitted: 2008-10-01
   Days after onset:215
Entered: 2008-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal pain, Activated partial thromboplastin time shortened, Blood calcium normal, Blood creatinine normal, Blood glucose increased, Blood group O, Blood potassium increased, Blood sodium normal, Blood urea increased, Bradycardia, Bradypnoea, Cardio-respiratory arrest, Cyanosis, Death, Decreased activity, Dehydration, Grand mal convulsion, Haematochezia, Haematocrit decreased, Haemoglobin normal, Hyponatraemia, Hypovolaemic shock, Ileostomy, Ileus paralytic, Intestinal anastomosis, Intestinal dilatation, Intestinal obstruction, Intestinal resection, Intussusception, Irritability, Metabolic disorder, Pain, Pharyngeal erythema, Platelet count increased, Prothrombin time shortened, Pyrexia, Rales, Rectal haemorrhage, Respiratory distress, Resuscitation, Rhesus antibodies positive, Status epilepticus, Surgery, Tachycardia, Vomiting, White blood cell count increased, X-ray abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Acute renal failure (broad), Haemolytic disorders (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), 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), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-03-15
   Days after onset: 15
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: Cough, Meckel diverticulum
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 02Mar2008, see textunit; Abdominal X-ray, 08Mar2008, see textunit; Abdominal X-ray, 12Mar2008, see textunit; Blood glucose, 02Mar2008, 94mg/dl; Blood grouping, 02Mar2008, ORh+; Calcium, 02Mar2008, 9.2mEq/l; Creatinine, 02Mar2008, 0.8mg/dl; Hematocrit, 02Mar2008, 34.6%; Hemoglobin, 02Mar2008, 11.6mg/dl; Leukocyte count NOS, 02Mar2008, 20470mm3; Partial thromboplastin time pr, 02Mar2008, 29..9s; Platelet count, 02Mar2008, 710000mm3; Potassium, 02Mar2008, 5.8mEq/l; Prothrombin time, 02Mar2008, 10.6s; Sodium, 02Mar2008, 134mEq/l; Urea, 02Mar2008, 62.6mg/dl
CDC Split Type: B0538764A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 4month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent medical conditions included Meckel diverticulum. Previous and/or concurrent vaccination included ROTARIX; GlaxoSmithKline; oral given on 13 December 2007. Six days before hospital admission the subject had cough. On 18 February 2008 the subject received 2nd dose of ROTARIX (oral). On 28 February 2008, 10 days after vaccination with ROTARIX, the subject experienced vomiting (10 episodes) abdominal distention and fever. On 02 March 2008 the subject was admitted at the emergency room presenting hypo activity, hyperemic pharynx, tachycardia, fever, abdominal pain with distention, dehydration, rectal tact with expulsion of fresh bloody stool and rectal bloody. The same day relevant test included abdominal x-ray showing intestinal occlusion and intussusception. Therefore the subject underwent a surgery which revealed Ileo Ileocolic intussusception with a necrotic mass (Meckel diverticulum considered congenital anomaly) and 300 cc of peritoneal free liquid. Intestinal resection of 10 cm was made with term to term anastomosis without further surgical correction. However the subject had unfavorable clinical evolution. He presented epileptic status with general tonic clonic seizures, hyponatremia and hypovolemic shock. On 08 March 2008 the subject showed abdominal distention. The same day the abdominal x-ray showed lack of intestinal air and rectal ampoule. The subject underwent again a surgery which showed intestinal occlusion, dysfunctional term to term anastomosis, damaged ileum and 100 cc of peritoneal liquid. A terminal ileum resection was required with a new ileal anastomosis. Post surgical evolution of the 2nd surgery was favorable for 2 days. On 11 March 2008 the subject presented irritability, abdominal distention, painfulness palpation and gastrobiliar liquid flow by nasogastric tube. Abdominal X-ray showed absence of intestinal air and air fluid levels. On 13 March 2008 the subject underwent a 3rd surgery which showed paralyzed colon, big intestinal dilatation of ileum and jejunum. The last anastomosis of the 2nd surgery was occluded in 90% of the lumen, loop to loop bridas, 60 cc of free serohematic liquid in abdominal cavity, bridas lysis, loops decompression and ileostomy of 2 stomas. The subject was discharged of surgery in favorable conditions. However on 14 March 2008 the subject presented crackles and slight respiratory distress without fever or infection evidence. On 15 March 2008 the subject had suddenly alveolar crackles in both lungs, cyanosis, bradycardia, bradypnea and finally cardio pulmonary arrest without response to resuscitation for 50 minutes. The physician considered the events were disabling, life threatening. The subject was treated with surgery, ceftriaxone, metamizole, metronadizole, vancomycin, omeprazole, THIOPENTAL, diazepam, phenytoin, clindamycin, metoclopramide, octreotide, salmeterol xinafoate, dexamethasone, dopamine, albumin, insulin, FUROSEMIDE, KETOROLAC and blood. The physician considered the events were possibly related to vaccination with ROTARIX. On 15 March 2008 the subject died from intestinal obstruction, intussusception and metabolic disorder.


VAERS ID: 329449 (history)  
Form: Version 1.0  
Age: 0.5  
Gender: Male  
Location: Foreign  
Vaccinated:2008-08-02
Onset:2008-09-10
   Days after vaccination:39
Submitted: 2008-10-21
   Days after onset:41
Entered: 2008-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Haematochezia, Intussusception, Mucous stools, 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0542196A

Write-up: This case was reported by a physician 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 ROTARIX (GlaxoSmithKline, oral) given on 23 June 2008. On 2 August 2008, the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 10 September 2008, 39 days after vaccination with ROTARIX, the subject started with vomiting and after experienced 8 currant jelly stools and fever. The patient was admitted at hospital with a suspicion of intussusception. A surgery was performed and the subject was hospitalised for 5 days. At the time of reporting the events were resolved. On 30 September, the subject went to the doctor for follow up and was in good general condition. The physician considered the events were almost certainly related to vaccination with ROTARIX.


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