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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: 391799 (history)  
Form: Version 1.0  
Age: 0.35  
Sex: Male  
Location: Foreign  
Vaccinated:2007-07-23
Onset:2007-07-30
   Days after vaccination:7
Submitted: 2010-06-30
   Days after onset:1066
Entered: 2010-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Abdominal mass, Diarrhoea, Ileectomy, Intussusception, Laparotomy, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0662910A

Write-up: This case was reported by a healthcare professional via another manufacturer (Fiocruz) and described the occurrence of intussusception in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 23 July 2007 the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 30 July 2007, 7 days after vaccination with ROTARIX, the subject experienced vomiting, diarrhea, abdominal distension with an abdominal mass. The subject was hospitalised. A x-ray was performed and showed intussusception which was resolved with umbilical laparotomy and ileal resection on 31 July 2007. At the time of reporting the events were resolved. No further information could be obtained; the case has been closed.


VAERS ID: 391800 (history)  
Form: Version 1.0  
Age: 0.16  
Sex: Male  
Location: Foreign  
Vaccinated:2007-04-27
Onset:2007-05-01
   Days after vaccination:4
Submitted: 2010-06-30
   Days after onset:1156
Entered: 2010-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA198A / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Haematochezia, Intussusception, Nausea, 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)

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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0662911A

Write-up: This case was reported by a healthcare professional via another manufacturer (Fiocruz) and described the occurrence of intussusception in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 27 April 2007, the subject received 1st dose of ROTARIX (oral). On 1 May 2007, 4 days after vaccination with ROTARIX, the subject experienced bloody stools, abdominal distension, vomiting and nausea. The subject was hospitalised and intussusception was diagnosed. The subject was treated with surgery and the events resolved. The 2nd dose of ROTARIX was administered on 27 June 2007 and if was unspecified if the events recurred. At the time of reporting, the case was under investigation due to possible acute appendicitis. No further information could be obtained; the case has therefore been closed.


VAERS ID: 391998 (history)  
Form: Version 1.0  
Age: 0.24  
Sex: Male  
Location: Foreign  
Vaccinated:2006-03-14
Onset:2006-03-17
   Days after vaccination:3
Submitted: 2010-07-02
   Days after onset:1567
Entered: 2010-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA035A / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Abdominal mass, Abdominal pain, Barium double contrast, Echography abnormal, Enema administration, Haematochezia, Intestinal operation, Intussusception, Irritability, Lethargy, Rectal haemorrhage, Rotavirus test negative, 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 obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Air contrast barium enema, 18Mar2006, not success; Echography, obstruction; Rotavirus test, negative; X-ray, obstruction
CDC Split Type: B0426366A

Write-up: This case was reported by the regulatory authorities and described the occurrence of intussusception in a male subject of 3 month-old who was vaccinated with ROTARIX (GlaxoSmithKline). On 14 March 2006 the subject received 1st dose of ROTARIX (oral). On 17 March 2006, 3 days after vaccination with ROTARIX, the subject experienced irritability and presented bloody stools. On 18 March 2006 the subject was hospitalised due to intussusception diagnosis. A contrast enema was attempted to solve the intestinal invagination without success, therefore the child was submitted to a surgery (without resection). Relevant test results included Rotavirus test in faeces which resulted negative. Regulatory authority reported that the events required hospitalization. On 22 March 2006 the events were resolved and the child was discharged. Follow up received on 21 June 2010 including the batch number. Follow up received on 24 June 2010: On 17 March 2006 the subject experienced vomiting, abdominal pain, abdominal distention, abdominal mass, rectal bleeding and lethargy. Relevant test included X-ray and echography which suggested obstruction.


VAERS ID: 391999 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: Foreign  
Vaccinated:2006-04-18
Onset:2006-05-17
   Days after vaccination:29
Submitted: 2010-07-02
   Days after onset:1507
Entered: 2010-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA082A / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Anal haemorrhage, Intestinal haemorrhage, Intestinal operation, Intussusception, Vomiting
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)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: RESPIRATORY TRACT INFECTION
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0426368A

Write-up: This case was reported by the regulatory authorities and described the occurrence of intussusception in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 18 April 2006 the subject received 1st dose of ROTARIX (oral). On 17 May 2006, 29 days after vaccination with ROTARIX, the subject experienced intense abdominal pain, vomiting and enterorrhagia. The subject was hospitalized and intussusception was diagnosed. A rectal injection of fisiological serum was attempted in order to solve the intestinal invagination without success. The subject was submitted to a surgery (without resection) and an intense ileocecocolic intussusception was observed. The subject was treated with GENTAMICIN, AMPICILLIN and metronidazole. Regulatory authority reported that the events required hospitalization. On 23 May 2006, the events were resolved and the subject was discharged. The vaccination course with ROTARIX was discontinued. Follow up received on 21 June 2010: Batch number. Follow up received on 24 June 2010: The subject had severe abdominal pain (intestinal pain), and anal bleeding. The clinical picture was preceded by upper respiratory tract infection.


VAERS ID: 392105 (history)  
Form: Version 1.0  
Age: 0.24  
Sex: Male  
Location: Foreign  
Vaccinated:2006-03-15
Onset:2006-04-01
   Days after vaccination:17
Submitted: 2010-07-06
   Days after onset:1556
Entered: 2010-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA035A / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Constipation, Crying, Faeces discoloured, Gastrointestinal pain, Intestinal haemorrhage, Intussusception, Irritability, Surgery, Ultrasound abdomen abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Ultrasound abdomen, intussuscept
CDC Split Type: B0426369A

Write-up: This case was reported by the regulatory authorities and described the occurrence of intussusception in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 15 March 2006, the subject received 1st dose of ROTARIX (oral). On 1 April 2006, 17 days after vaccination with ROTARIX, the subject was irritable and cried probably related to the intestinal cramps. On 15 April 2006, the subject experienced constipation associated with worsening intestinal cramps. On 01 May 2006, the subject was constipated and evacuated dark stools. After the introduction of a suppository in his rectum was observed that the subject presented enterorrhagia. The subject was hospitalized, and after performing an abdominal ultrasound, intussusception was diagnosed. On 02 May 2006, the subject was submitted to a surgery (without intestinal resection). Regulatory authority reported that events required hospitalization. On 07 May 2006, he was discharged completely recovered. On 19 May 2006, the subject received 2nd dose of ROTARIX (oral). At the time of reporting, no adverse event had occurred. Follow-up received on 5 May 2010: The vaccine''s batch number was provided.


VAERS ID: 392107 (history)  
Form: Version 1.0  
Age: 0.27  
Sex: Female  
Location: Foreign  
Vaccinated:2006-03-15
Onset:2006-03-16
   Days after vaccination:1
Submitted: 2010-07-06
   Days after onset:1572
Entered: 2010-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA035A / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Crying, Intestinal haemorrhage, Intestinal malrotation, Intussusception, Irritability, Laparotomy, Ultrasound scan abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Congenital, familial and genetic disorders (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Low weight
Preexisting Conditions: Congenital intestinal malformation
Allergies:
Diagnostic Lab Data: Ultrasound scan, 17Mar2006, IS
CDC Split Type: B0416785A

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). Concurrent medical conditions included congenital intestinal malformation (malrotation) and low weight. No concurrent medications or vaccines were reported. On 15 March 2006, the subject received 1st dose of ROTARIX (oral). On 17 March 2006, 2 days after vaccination with ROTARIX, the subject experienced enterorrhagia, blown abdomen and irritability. On the same day, she was hospitalised. An ultrasound was performed and intussusception was diagnosed. On 17 march 2006, a surgery (laparotomy) was performed which confirmed the diagnosis of ileocecocolic intussusception and evidenced a congenital intestinal malrotation. The reporting physician considered the events to be life threatening. At the time of reporting the events were improved. The physician considered the events were unlikely to be related to vaccination with ROTARIX and more likely to be related to the congenital intestinal malrotation which according to him would have been a contra-indication to vaccination with ROTARIX. In a follow-up received on 01 June 2006, the relationship had been changed to unknown and the events were no more considered as life threatening. It was also mentioned that the child had recovered on 22 March 2006 and was discharged on the same day. No tests for rotavirus were found in the medical records. Follow up information received on 05 May 2010: This case was also reported by a healthcare professional via another manufacturer (Fiocruz). On 15 March 2006, the subject received 1st dose of ROTARIX (oral). On 16 March 2006, 1 day after vaccination with 1st dose of ROTARIX, the subject experienced inconsolable crying leading to a hospital. The subject was hospitalised. Ultrasonography evidenced intussusception. She was submitted to laparotomy. Intestinal malrotation and ileocecal-colic intussuception were corrected. The event evolved to cure.


VAERS ID: 392108 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Male  
Location: Foreign  
Vaccinated:2006-09-26
Onset:2006-10-03
   Days after vaccination:7
Submitted: 2010-07-06
   Days after onset:1372
Entered: 2010-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Abdominal pain, Death, Haematochezia, Intussusception, Rectal haemorrhage, Sepsis, 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), Sepsis (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-10-06
   Days after onset: 3
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: X-ray, 04Oct2006, IS
CDC Split Type: B0662987A

Write-up: This case was reported by a healthcare professional via another manufacturer (Fiocruz) and described the occurrence of intussusception in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 26 September 2006, the subject received 1st dose of ROTARIX (oral, lot number not provided). On 3 October 2006, 7 days after vaccination with ROTARIX, the subject experienced vomiting, abdominal pain, rectal bleeding, bloody stools and abdominal distension which leaded to medical care. On 3 October 2006, the subject was hospitalised. On 4 October 2006, X-ray suggested intussusception leading to surgery without resection. Sepsis leaded to death on 06 October 2006. Cause of death was not reported. It was unknown whether an autopsy was performed.


VAERS ID: 392109 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Male  
Location: Foreign  
Vaccinated:2006-01-02
Onset:2006-01-05
   Days after vaccination:3
Submitted: 2010-07-06
   Days after onset:1642
Entered: 2010-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS X41CA015A1R1 / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Barium double contrast, Crying, Gastrointestinal disorder, Haematochezia, Intestinal obstruction, Intussusception, Irritability, Rectal haemorrhage, Ultrasound abdomen abnormal, 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), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Air contrast barium enema, 07Jan2006, see text; Ultrasound abdomen, 07Jan2006, abnormal
CDC Split Type: B0407170A

Write-up: This case was reported by a physician and described the occurrence of ileocolic intussusception in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was previously healthy and breastfed. On 2 January 2006 the subject received a 1st dose of ROTARIX (oral). On 05 January 2006, 3 days following vaccination, the subject developed abdominal pain, bloody faeces and irritability (described as persistent crying). On 06 January 2006, 4 days after vaccination, the subject was admitted at the hospital and an ultra-sound was performed. The ultrasound examination of the abdomen showed sore size increased ganglia in the intestine. Ileocolic intussusception was diagnosed. The subject was submitted to a air contrast barium enema procedure which resolved the intussusception. No further medication was given. The physician considered the event was clinically significant and possibly related to vaccination with ROTARIX. The physician associated the event temporally (but not causally) with ROTARIX. The vaccination course has been discontinued. Follow up information received on 05 May 2010: This case was also reported by a healthcare professional via another manufacturer (Fiocruz). On 2 January 2006, the subject received a 1st dose of ROTARIX (oral). The vaccine was administered in a private hospital. On 06 January 2006, 4 days after vaccination with 1st dose of ROTARIX, the subject experienced vomiting every 15 minutes and rectal bleeding. The subject was hospitalised. Ultrasound guided saline enema was administered for intestinal "deobstruction" and vomit stopping. The event evolved to cure.


VAERS ID: 392111 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Female  
Location: Foreign  
Vaccinated:2006-07-10
Onset:2006-07-14
   Days after vaccination:4
Submitted: 2010-07-06
   Days after onset:1453
Entered: 2010-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA092A / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Abdominal pain, Explorative laparotomy, Haematochezia, Hypotension, Intussusception, Lethargy, Pallor, Rectal haemorrhage, Small intestinal intussusception reduction, Vomiting, X-ray abnormal
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0662986A

Write-up: This case was reported by a healthcare professional via another manufacturer FIOCRUZ and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (manufacturer unspecified; unknown route of administration) given on 10 July 2006. On 10 July 2006, the subject received 2nd dose of ROTARIX (oral). On 14 July 2006, 4 days after vaccination with 2nd dose of ROTARIX, the subject experienced lethargy, pallor, vomiting, abdominal pain, rectal bleeding, bloody stools, abdominal distension and hypotension. On 15 July 2006, the subject was hospitalised; intussusception was diagnosed leading the child to exploratory laparotomy. Ileocecal intussusception was reduced without resection. X-ray suggested "ortoestase". At the time of reporting the events were resolved.


VAERS ID: 392115 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Foreign  
Vaccinated:2010-06-26
Onset:2010-06-26
   Days after vaccination:0
Submitted: 2010-07-06
   Days after onset:10
Entered: 2010-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CA655A / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Anaphylactic reaction, Barium double contrast, Blood electrolytes normal, Body temperature normal, Capillary disorder, Capillary nail refill test abnormal, Gastrointestinal obstruction, Haematochezia, Haematocrit normal, Intussusception, Neutrophil percentage, Pallor, Platelet count normal, Pulse pressure decreased, Somnolence, Ultrasound abdomen abnormal, Vomiting, White blood cell count normal, X-ray abnormal
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), 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), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 27Jun2010, Obstruction; Blood neutrophils, 26Jun2010, 60%; Blood pressure, 26Jun2010, 120/80mmHg; Body temperature, 26Jun2010, 37.6Deg C; Hematocrit, 26Jun2010, 36%; Platelet count, 26Jun2010, 300000/mm3; Pulse rate, 26Jun2010, 130beats/min; Ultrasound abdomen, 27Jun2010, Intussuscept; White blood cell count, 26Jun2010, 10700/mm3
CDC Split Type: B0663295A

Write-up: This case was reported by a physician and described the occurrence of anaphylaxis in a 6-month-old male subject who was vaccinated with INFANRIX HEXA (GlaxoSmithKline), ROTARIX. On 26 June 2010, the subject received unspecified dose of INFANRIX HEXA (intramuscular, unknown injection site), unspecified dose of ROTARIX (oral). On 26 June 2010, 20 minutes after vaccination with INFANRIX HEXA and ROTARIX, the subject was mildly drowsy and pale. He was brought back home where he had 10 times clear yellowish vomitings. He had no diarrhea. Six hours after vaccination, the subject was markedly pale and drowsy. He was brought to hospital and was hospitalised. At admission, the subject was drowsy, pale, had a weak peripheral pulse and delayed capillary refill. The temperature was 37.6 Deg C, blood pressure 120/80 mmHg and pulse rate 130 beats/min. The subject was treated with intravenous fluid(s). Anaphylaxis was diagnosed, leading to treatment with adrenaline and antihistamine. The laboratory tests performed showed hematocrit 36%, white blood cell count 10700/mm3, neutrophils 60%, platelet count 300000/mm3 and normal electrolyte. On 27 June 2010, the subject experienced bilious vomiting and current jelly stool. The abdomen x-ray showed abdominal obstruction and abdomen ultrasound revealed intussusception. The intussusception was closely reduced by medical air (Air). The subject was treated with ROCEPHIN. The subject left the hospital the 3rd day. On 28 June 2010, the subject was in a better condition and was discharged from hospital with oral antibiotics (Antibiotic unspecified) as treatment. At the time of reporting the events were resolved. The physician considered the anaphylaxis was almost certainly related to vaccination with INFANRIX HEXA. The physician concluded this case as a case of anaphylaxis due to INFANRIX HEXA. He considered that the onset of the intussusception was too close to be related to the vaccination.


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