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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: 340434 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:2008-12-08
Onset:2009-01-19
   Days after vaccination:42
Submitted: 2009-02-23
   Days after onset:35
Entered: 2009-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR - / UNK - / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Haematochezia, Intussusception, Irritability, Laparotomy, Respiratory disorder, Tachypnoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Ischaemic colitis (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (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? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0559945A

Write-up: This case was reported by a physician and described the occurrence of ileocolic intussusception in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included bacillus CALMETTE-GUERIN vaccine; unknown manufacturer; intradermal given on 28 September 2008; DTaP+ IPV+ HIB; manufacturer unspecified; intramuscular given on 8 December 2008; HEP B; manufacturer unspecified; intramuscular given on 28 September 2008 and 8 December 2008; pneumococcal vaccines (unknown manufacturer); intramuscular given on 8 December 2008. On 8 December 2008 the subject received 1st dose of ROTARIX (oral). On 19 January 2009, 42 days after vaccination with ROTARIX, the subject started with polypnea, respiratory difficulty and irritability. On 20 January 2009 the subject was brought to the emergency room where it was found bloody stools and MORCILLA''s signs in the abdomen. Therefore intussusception was suspected. Ileocolic intussusception was corroborated by laparotomy and it was remitted by taxis without complications and good clinical evolution. None laboratory test was performed. On 24 January 2009 the subject was discharged. The physician considered the events were clinically significant (or requiring intervention). On 24 January 2009, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 340437 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Male  
Location: Foreign  
Vaccinated:2008-09-22
Onset:2008-10-15
   Days after vaccination:23
Submitted: 2009-02-23
   Days after onset:131
Entered: 2009-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal pain, Anorexia, Haematochezia, Intussusception, Irritability, Laparotomy, Mucous stools, Nausea, Vomiting, X-ray abnormal
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), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 16Oct2008, IS
CDC Split Type: B0560449A

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 bacillus calmette-guerin vaccine (non-gsk); non-GSK manufacturer; intradermal given on 23 May 2008; DTPa-IPV-HIB; manufacturer unspecified; intramuscular given on 21 July 2008 and 22 September 2008; hepatitis B vaccine recombinant; manufacturer unspecified; intramuscular given on 23 May 2008 and 21 August 2008; ROTARIX; GlaxoSmithKline; oral given on 21 July 28; pneumococcal vaccines (non-gsk); manufacturer unspecified; intramuscular given on 21 August 2008. The subject''s medical conditions included a healthy baby. On 22 September 2008 the subject received 2nd dose of ROTARIX (oral) lot number not provided. On 15 October 2008, 23 days after vaccination with ROTARIX, the subject started with abdominal pain, irritability, nausea, vomiting and hyporexia. On 16 October 2008 the subject was admitted to the emergency room. Bloody stools like black currant jelly were found. Relevant test included abdominal x-ray which showed fluid levels and dilated bowel loops. Plain abdominal radiography showed non specific abnormalities. Therefore the same day the subject underwent a laparotomy which showed ileocecocolic intussusception. It was remitted by taxis without complications. No bowel resection was required. On 19 October 2009 the subject was discharged in good clinical conditions. The subject was hospitalized for 4 days and the physician considered the events were clinically significant (or requiring intervention). The physician considered the events were possibly related to vaccination with ROTARIX.


VAERS ID: 340694 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Male  
Location: Foreign  
Vaccinated:2008-12-17
Onset:2008-12-19
   Days after vaccination:2
Submitted: 2009-02-25
   Days after onset:68
Entered: 2009-02-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA566A / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Crying, Intussusception
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (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? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0561189A

Write-up: This case was reported by a physician and described the occurrence of suspected intussusception in a 4-month-old male subject who was vaccinated with ROTARIX. On 17 December 2008, the subject received 2nd dose of ROTARIX (oral). On 19 December 2008, 48 hours after vaccination with ROTARIX, the subject started to cry inconsolably. He was crying for 3.5 hours and then suddenly stopped. The subject experienced abdominal pain. Intussusception was suspected (transitional by doctors'' opinion). This case was assessed as medically serious by GSK. On 19 December 2008, the events were resolved. The physician considered the events were possibly related to vaccination with ROTARIX. No follow up information is expected.


VAERS ID: 340695 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2009-02-02
Onset:2009-02-06
   Days after vaccination:4
Submitted: 2009-02-25
   Days after onset:19
Entered: 2009-02-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA514A / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Abnormal behaviour, Crying, Diarrhoea, Disturbance in attention, Enema administration, Intussusception, Lymphadenitis, Ultrasound abdomen abnormal
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (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? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Ultrasound abdomen, 06Feb2009, see text
CDC Split Type: B0561190A

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). On 2 February 2009, the subject received 1st dose of ROTARIX (oral). On 6 February 2009, 4 days after vaccination with ROTARIX, the subject experienced 1 liquid stool, abdominal pain and strange behavior. He was crying. It was hard to make contact with him and he seemed distant. The subject was hospitalised for 2 days. An abdominal ultrasound was performed and showed mesenteric lymphadenitis with double intussusception which was resolved by air inflation. The subject was discharged from hospital on 7 February 2009. On 25 February 2009, the events were resolved. The physician considered the events were almost certainly related to vaccination with ROTARIX. No further information was expected; therefore the case has been closed.


VAERS ID: 340915 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2009-01-29
Onset:2009-02-03
   Days after vaccination:5
Submitted: 2009-03-02
   Days after onset:27
Entered: 2009-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Barium enema abnormal, Haematochezia, Intestinal resection, Intussusception, Surgery, Ultrasound abdomen abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (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 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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Ultrasound abdomen, 04Feb2009, abnormal
CDC Split Type: B0561135A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history. On 29 January 2009, the subject received 1st dose of ROTARIX (oral). Lot number not provided. On 3 February 2009, 5 days after vaccination with ROTARIX, the subject started with vomiting. On 4 February 2009, the subject received an anti-emetic drug but vomiting continued with blood in stools. An ultrasound was performed and confirmed the diagnosis of intussusception which was reduced by Barium enema. But the intussusception was still present and a surgery was done on 5 February 2009. A small segment of intestine with Merckel Diverticulum was resected. The subject was hospitalized and the physician considered the events were clinically significant (or requiring intervention). Abdominal radiography performed showed fluid levels and dilated bowel loops. Air or liquid contrast Enema performed demonstrated invagination of the intestine. Abdominal ultrasound showed visible intussusception or soft tissue mass. At the time of reporting the events were improved. The physician considered the events were possibly related to vaccination with ROTARIX.


VAERS ID: 341185 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Foreign  
Vaccinated:2008-01-16
Onset:2008-01-18
   Days after vaccination:2
Submitted: 2009-03-05
   Days after onset:412
Entered: 2009-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA525 / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdomen scan normal, Crying, Echography abnormal, Enema administration, Hypotonia, Intussusception, Pallor, Surgery, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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: Cow''s Milk intolerance
Preexisting Conditions: There was no personal or family history of intestinal intussusception or bowel anomaly. There was no past medical history of intra-abdominal surgery or congenital intestinal malformation.
Allergies:
Diagnostic Lab Data: Abdomen scan, Jan2008, showed no image of a visible intussusception; Echography, Jan2008, showed an ileo-caeco intussusception
CDC Split Type: B0514039A

Write-up: This case was reported by a physician via a GSK representative and described the occurrence of intussusception of intestine in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 16 January 2008, the subject received a 1st dose of ROTARIX (oral, batch A41CA525). On 18 January 2008, 2 days after vaccination with ROTARIX, the subject developed hypotonus. On 19 January 2008, he was hospitalized. A diagnosed of intussusception of intestine was made. He was inefficiently treated with enema. On 20 January 2008, a surgery was performed and was successful in reducing the intussusception. Hypotonus resolved within an unspecified delay. Causality relationship was not assessed by the reporter. Follow up on 09 September 2008 by the physician: There was no personal or family history of intestinal intussusception or bowel anomaly. The subject had no past medical history of intra-abdominal surgery or congenital intestinal malformation. Relevant medical history included intolerance to cow''s milk proteins. The subject was fed with a milk without cow''s milk proteins. Vaccinal history included a first dose of INFANRIXQUINTA (GlaxoSmithKline, batch A20CA383A) and PREVENAR (Wyeth Labs, batch 28259). Hypotonus was no more mentioned. On 19 January 2008, three days after vaccination with the first dose of ROTARIX, the subject presented with vomiting, episodes of pallor and cried. The subject was hospitalized. Abdominal scan showed no image of a visible intussusception. Abdominal echography showed an ileo-caeco intussuception. No radiography was performed. After inefficiency of enema, the subject underwent surgical reduction without resection on 20 January 2008. There was no complication. Intussusception was considered as resolved on 20 January 2008. On 12 February 2008 and on 13 March 2008, the subject received the second and third dose of INFANRIXQUINTA and PREVENAR. The physician considered the events as clinically significant and possibly linked to vaccination with ROTARIX and possibly linked to cow''s milk proteins intolerance. This case has been closed; no more information will be available.


VAERS ID: 341295 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2009-02-14
Onset:2009-02-17
   Days after vaccination:3
Submitted: 2009-03-06
   Days after onset:17
Entered: 2009-03-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA688A / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Culture stool positive, Culture urine positive, Enteritis, Explorative laparotomy, Intussusception, Proteus infection, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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: Stool culture, Feb2009, it grew Proteus mirabilis; Urine culture, Feb2009, it grew Proteus mirabilis
CDC Split Type: B0562508A

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. On 14 February 2009, the subject received 1st dose of ROTARIX (oral). On 17 February 2009, 3 days after vaccination with 1st dose of ROTARIX, the subject experienced fever. On 18 February 2009, the subject experienced vomiting. On 19 February 2009, the subject experienced abdominal distension. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). The subject was diagnosed to have intussusception thus an exploratory laparotomy was done on 20 February 2009 with findings of intussusception and enteritis of the ileum which was noted to be more severe than the intussusception. On follow up of the laboratory results, on culture of urine and the stool, it grew Proteus mirabilis thus the assessment was more on the infection and subject was continued on with antibiotics. The subject was still in the hospital at time of reporting. At the time of reporting the outcome of the events was unspecified. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 341450 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Female  
Location: Foreign  
Vaccinated:2006-10-28
Onset:2009-02-24
   Days after vaccination:850
Submitted: 2009-03-10
   Days after onset:13
Entered: 2009-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA115A / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal mass, Barium enema, Enema administration, Intussusception, Laparotomy, Ultrasound abdomen abnormal, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, Feb2009, intussuscept; Ultrasound abdomen, Feb2009, intussuscept
CDC Split Type: B0562576A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 32-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous vaccination included ROTARIX (GlaxoSmithKline, oral) given on 16 September 2006. On 28 October 2006, the subject received 2nd dose of ROTARIX (oral). On 24 February 2009, 2 years after vaccination with ROTARIX, the subject experienced vomiting, abdominal distention and abdominal mass. The subject was hospitalised. Abdominal ultrasound and x-ray confirmed diagnosis of intussusception. The subject had a Barium reduction which failed and the intussusception was reduced by laparotomy. At the time of reporting the events were improved.


VAERS ID: 341504 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2009-01-29
Onset:2009-02-01
   Days after vaccination:3
Submitted: 2009-03-11
   Days after onset:37
Entered: 2009-03-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA698A / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Intussusception, Surgery
SMQs:, Gastrointestinal obstruction (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: D0060791A

Write-up: This case was reported by a foreign regulatory authority (DE-PEI-PEI2009004209) and described the occurrence of ileocolic intussusception in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject has no underlying or concurrent medical conditions. On 29 January 2009 the subject received the first dose of ROTARIX (0.5 ml, oral). Approximately three days post vaccination with ROTARIX, on 01 February 2009, the subject experienced ileocolic intussusception. The subject was hospitalised for the event for an unknown period of time. Infectious enteritis was excluded by differential diagnosis. The event was clinically significant requiring intervention. On 01 February 2009, the subject underwent surgery (manual disinvagination) for ileocolic intussusception. Post surgery, on 01 February 2009, the event was resolved. No further information will be available.


VAERS ID: 341945 (history)  
Form: Version 1.0  
Age: 0.1  
Gender: Male  
Location: Foreign  
Vaccinated:2008-12-10
Onset:2009-01-16
   Days after vaccination:37
Submitted: 2009-03-16
   Days after onset:58
Entered: 2009-03-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA596A / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal pain, Anaemia, Crying, Enema administration, Gastrointestinal necrosis, Gastrointestinal oedema, Haematochezia, Hypovolaemia, Intestinal anastomosis, Intestinal ischaemia, Intestinal perforation, Intestinal resection, Intussusception, Laparotomy, Mucous stools, Pain, Surgery, Transfusion, Ultrasound abdomen abnormal, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Haematopoietic erythropenia (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 (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Hypersensitivity (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, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: EPICANTHUS, PREAURICULAR APPENDICES
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Examinations: X-ray of abdomen on 16 January 2009: Distended intestinal loops, no detection of free air or fluid levels. Distinct mucosal haemorrhagia, especially in large bowel, with spot-like haemorrhagic necroses and distinct, unspecific reactive follicular hyperplasia of lymphatic tissue in small bowel and appendix; sample lymphatic tissue in small bowel and appendix; sample lymph nodes without pathologic findings; no sign for malignity.
CDC Split Type: D0060443A

Write-up: This case was reported by a physician, via a sales representative, and described the occurrence of intussusception in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 10 December 2008 the subject received 1st dose of ROTARIX (oral). On 16 January 2009, 37 days after vaccination with ROTARIX, the subject underwent surgery (not other specified) because of intussusception. The event was clinically significant (or requiring intervention). Follow-up information was received on 18 February 2009. No concurrent medical conditions or concurrent medications were known to the reporter. The subject was hospitalised and underwent intestinal surgery with resection. At the time of reporting the event was resolved. The physician considered the causality was not assessable. Follow-up information was received on 11 March 2009 including the targeted follow-up questionnaire (incomplete) and a hospital report. Family history included no intussusception or bowel abnormalities. The subject''s medical history did not include previous intra-abdominal surgery, congenital intestinal malformation, intestinal polyps, Meckels diverticulum, intestinal vascular malformations, cystic fibrosis, Hirschsprung disease, other gastrointestinal malformation and dysfunction. The subject was diagnosed with intussusception. Symptoms started on 16 January 2009 and were completely resolved on 27 January 2009 (day of discharge from hospital). Plain abdominal radiograph and abdominal ultrasound were performed, but no computerized tomogram. Surgery, performed on 16 January 2009 demonstrated invagination. The child had a bowel resection. Surgery was without complications. According to the hospital report the subject was suddenly crying and vomiting in the morning of 16 January 2009 around 10:30. Additionally there were recurrent bloody stools. When admitted to hospital the subject was in good general condition, but with palpable abdominal resistance (left middle and lower belly), local pain on pressure and moderate peristaltics. In diaper the typical raspberry jelly-like stool was found. Under narcosis hydrostatic disinvagination was tried. Intussusceptum could be followed to the colon descendens, and by sonogram to the colon ascendens. Complete disinvationation did not succeed. During the following abdominal laparotomy intussusception to the Colon ascendens was detected. No macroscopic cause like lymphadenitis, Meckels diverticulum or lymphangioma could be found. Careful disinvagination by Hutchinson''s manoeuvre was started, but was difficult and caused local rupture of coecal serosa. The invaginated part of the bowel was ischemic end oedematous. At the terminal ileum at the junction to coecum, intestinal wall was damaged, and only covered by serosa. Stretching of serosa immediately caused opening to the intestinal lumen. Because of this it was decided to perform ileosacral resection and ileoascendostomia by end-to-end-anastomosis. Central vein catheter was implated in the right vena jugularis externa, followed by the infusion therapy and protection with SPIZEF and METRONIDAZOL. Because of hypovolemic anaemia, blood transfusion was performed on 17 January 2009. On the third day post surgery nutrition was slowly re-established, which was well tolerated by the subject. Further hospitalization was without complications. Because of unusual minor anomaly (including epicanthus inversus, pseudostabism and preauricular appendices) genetic examination was performed, but results were not available at the time of reporting. When discharged on 27 January 2009 the subject was in undisturbed condition with non-irritable wounds, soft abdomen and normal nutrition. No further information will be available.


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https://www.medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=29&SYMPTOMS[]=Intussusception_%2810022863%29&VAX[]=RV1&REPORT_YEAR_LOW=2008&REPORT_MONTH_LOW=02&REPORT_YEAR_HIGH=2014&REPORT_MONTH_HIGH=12


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