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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: 449894 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Male  
Location: Foreign  
Vaccinated:2012-02-04
Onset:2012-02-04
   Days after vaccination:0
Submitted: 2012-02-20
   Days after onset:16
Entered: 2012-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / SC
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA405CA / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Computed tomographic colonography, Enema administration, Intussusception, Ultrasound abdomen abnormal, X-ray
SMQs:, Retroperitoneal fibrosis (broad), 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? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Computed tomographic colonography, 04Feb2012, unknown; Ultrasound scan, 04Feb2012, target sign; X-ray, 04Feb2012, unknown
CDC Split Type: B0780757A

Write-up: This case was reported by a physician and described the occurrence of invagination of intestine in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 4 February 2012, the subject received unspecified dose of ROTARIX (1.5 ml, oral, batch number not provided). On 4 February 2012, 2 hours after vaccination with ROTARIX, the subject experienced invagination of intestine. The physician considered the event was clinically significant. On 4 February 2012, the event was resolved. Additional information received on 13 February 2012. Batch number was provided. On 04 February 2012, high enema was performed. On 04 February 2012, X-ray photography (Xp), ultrasonography, and retrograde colonography were performed. The ultrasonography revealed a target sign.


VAERS ID: 450104 (history)  
Form: Version 1.0  
Age: 0.29  
Sex: Female  
Location: Foreign  
Vaccinated:2012-01-11
Onset:2012-01-21
   Days after vaccination:10
Submitted: 2012-02-22
   Days after onset:32
Entered: 2012-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA405AA / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Crying, Enema administration, Haematochezia, Intussusception, Mucous stools
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Ischaemic colitis (broad), 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: B0778430A

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). On an unspecified date, the subject received unspecified dose of ROTARIX (oral, batch number not provided). On 21 January 2012, at an unspecified time after vaccination with ROTARIX, the subject experienced invagination of intestine. The physician considered the event was clinically significant (or requiring intervention). At the time of reporting the event was resolved. Follow-up information received on 16 February 2012: Concurrent vaccination included first dose of ROTARIX (GlaxoSmithKline) (oral) given on 14 December 2011. Batch number was provided. On 11 January 2012, the subject received the 2nd dose of ROTARIX (oral). On 21 January 2012, from around 5h00, 10 days after vaccination with ROTARIX, the subject cried bitterly with tears. Around noon, the subject visited the reporting physician''s hospital. She was given an enema, for which mucous and bloody stool were observed. She was transferred to another hospital and a diagnosis of intussusception was made. The physician considered the events were clinically significant (or requiring intervention). On 22 January 2012, the events were resolved.


VAERS ID: 450105 (history)  
Form: Version 1.0  
Age: 0.55  
Sex: Female  
Location: Foreign  
Vaccinated:2011-11-28
Onset:2011-12-15
   Days after vaccination:17
Submitted: 2012-02-22
   Days after onset:69
Entered: 2012-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA405AA / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal mass, Cough, Diarrhoea, Enema administration, Inappropriate schedule of drug administration, Intussusception, Nasopharyngitis, Pyrexia, Rhinorrhoea, Ultrasound abdomen abnormal, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Medication errors (narrow), 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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Tipepidine hybenzate; Cyproheptadine HCl; Carbocisteine
Current Illness: Atopic Dermatitis; Nasopharyngitis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature, 14Dec2011, 37.1deg.C; Ultrasound scan, 15Dec2011, target sign
CDC Split Type: B0781308A

Write-up: This case was reported by a physician and described the occurrence of invagination of intestine in an infant female subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 28 November 2011, the subject received the 1st dose of ROTARIX (1.5 ml, oral). On 15 December 2011, 17 days after vaccination with ROTARIX, the subject visited the reporting physician''s hospital,and she was admitted to another hospital for suspected invagination of intestine. On 16 December 2011, the event resolved, and the subject was discharged from the hospital. The subject was hospitalised. The physician considered the event was related to vaccination with ROTARIX. It was unknown whether the event was caused by ROTARIX, but there was a possibility. Additional information received on 17 February 2012: The subject''s medical conditions included atopic dermatitis and nasopharyngitis. From around 07 December 2011, the subject presented with cough and snivel. On 14 December 2011, at 15:44, cough, snivel, and pyrexia of 37.1 degrees centigrade persisted, for which the subject visited the reporting physician''s hospital. A diagnosis of common cold was made, and above-mentioned ADVERIN, PERIACTIN, and MUCODYNE was prescribed. On 15 December 2011, the subject vomited profusely for the first time and experienced diarrhoea. On 15 December 2011, at 11:40, the subject vomited yellow fluid (for the second time) and experienced diarrhoea. No bloody stool was observed. On 15 December 2011, at 12:08, the subject visited the reporting physician''s department in slightly low spirits. A mass (+) developed on the upper abdominal. The target sign was revealed on abdominal ultrasound scan. Although the scan was performed only one hour and a half after the onset, the result was typical image. A diagnosis of intussusception was made. She was hospitalized to A hospital on referral. A diagnosis of the same disease was made at A hospital, for which a high-pressure enema (an air reduction) was performed, reduction of the intestinal tract was obtained, and she was hospitalized for observation until 16 December 2011. She became well and lively with which she was discharged from A hospital. On 17 December 2011, at 11:56, the patient revisited the reporting physician''s department. Although she presented with cough and snivel, she became well and lively. The reporter considered that the intussusception was related to ROTARIX and common cold. It was unknown whether the symptom was caused by ROTARIX, but there was a possibility. The reason why the vaccination had been performed beyond the first six months of life was that there was a background that an acquaintance of the subject''s mother had been hospitalized for serious rotavirus infection; therefore, the subject was explained that the vaccinations was recommended to be usually given within the first six months of life, and then the vaccination was performed. The reporting physician would never give vaccinations beyond the first six month of life, not for any reason. No examinations other than ultrasound scan were performed at the reporting physician''s department.


VAERS ID: 451121 (history)  
Form: Version 1.0  
Age: 0.32  
Sex: Male  
Location: Foreign  
Vaccinated:2009-10-04
Onset:2009-12-13
   Days after vaccination:70
Submitted: 2012-03-05
   Days after onset:813
Entered: 2012-03-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Apathy, Cough, Enema administration, Gastrointestinal disorder, Gaze palsy, Influenza, Intussusception, Lymphadenitis, Malaise, Pallor, Pyrexia, Ultrasound abdomen abnormal
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Gastrointestinal obstruction (narrow), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Nasal (unspecified)
Current Illness: Mesenteric adenolymphitis; nasopharyngitis
Preexisting Conditions: Born at 39 weeks of amenorrhea (birth weight 3.55 kg). Formula feeding with a diversified diet. No relevant medical history.
Allergies:
Diagnostic Lab Data: Body temperature, Dec2009, increased; Ultrasound scan, 13Dec2009, see text; 13 December 2009, Abdominal ultrasound scan: suggestive of an ileocolic intussusception and mesenteric adenolymphitis
CDC Split Type: B0784894A

Write-up: This case was reported by a CRO during a prospective study and described the occurrence of intussusception in a 6-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject weighed 8.5 kg and measured 70 cm. He was born at 39 weeks of amenorrhea (birth weight 3.55 kg). The subject was fed with formula feed with a diversified diet. He had no relevant medical history. Within the 15 days before the events, the subject had a nasopharyngitis and was treated by nose washing with an unspecified nasal solution. Concurrent vaccinations included a first dose of INFANRIX HEXA and a first dose of PREVENAR given on 07 August 2009, a second dose of INFANRIXQUINTA given on 24 September 2009, a third dose of INFANRIX HEXA (less than 4 weeks after the second dose, drug dose administration interval too short), a second dose of PREVENAR given on 07 October 2009 and one dose of PANENZA (non-gsk). On 04 October 2009, the subject received his second dose of ROTARIX (batch and route unknown). First symptoms occurred on 13 December 2009, about 70 days after administration of the second dose of ROTARIX. On that date the subject was admitted to emergency unit then hospitalized. Report from emergency unit was not available. On admission, the subject presented with pallor, apathy, malaises with ocular revulsion and abdominal pain. Abdominal ultrasound scan was suggestive of an ileocolic intussusception and evidenced a mesenteric adenolymphitis (incidental event). Intussusception was completely reduce by air enema. Clinical course of gastrointestinal disorders was favourable without recurrence of malaise and abdominal pain and normalization of bowel movement without vomiting. But the subject had a febrile peak with cough suggestive of flu symptoms. Hospitalization was prolonged 48 hours for medical monitoring. On 16 December 2009, the subject was discharged from hospital. Brighton score was quoted at 1 by a scientific committee. At the time of reporting, the events were resolved. The reporter''s assessment was not provided.


VAERS ID: 451123 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: Foreign  
Vaccinated:2010-10-21
Onset:2010-12-24
   Days after vaccination:64
Submitted: 2012-03-05
   Days after onset:437
Entered: 2012-03-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal pain, Ascites, Constipation, Crying, Enema administration, Inappropriate schedule of drug administration, Intussusception, Rectal haemorrhage, Ultrasound abdomen abnormal, Vomiting, X-ray abnormal
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), 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), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Medication errors (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? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Born at 41 weeks of amenorrhea (birth weight 3.4 kg). Formula feed with a diversified diet. No relevant medical history.
Allergies:
Diagnostic Lab Data: Abdominal x-ray, 27Dec2010, intussusception; Body temperature, 27Dec2010, normal; Ultrasound scan, 27Dec2010, intussusception
CDC Split Type: B0784873A

Write-up: This case was reported by a CRO during a prospective study and described the occurrence of intussusception in a 6-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject weighed 8.78 kg and measured 71 cm. He was born at 41 weeks of amenorrhea (birth weight 3.4 kg). The subject was fed with formula feed with a diversified diet. He had no relevant medical history. Within the 15 days before the events, the subject had no infectious disease and did not received any medication. Concurrent vaccinations included a first dose of INFANRIX HEXA and a first dose of PREVENAR given on 28 August 2010, a second dose of INFANRIX QUINTA given on 23 September 2010 (less than 4 weeks after the second dose, drug dose administration interval too short), a third dose of INFANRIX HEXA, a second dose of PREVENAR and one dose of unspecified meningitis vaccine on 21 October 2010 and one dose of tuberculosis vaccine (BCG) given on 23 November 2010. On 21 October 2010, the subject received a first dose of ROTARIX (batch and route unknown) associated with one dose of INFANRIX HEXA, one dose of PREVENAR and one dose of meningitis vaccine. First symptoms occurred on 24 December 2010, about 2 months after administration of the first dose of ROTARIX, with abdominal pain and intermittent abnormal crying. On 27 December 2010, the subject was admitted to emergency unit then transferred in an other hospital for hospitalized. Report from emergency unit was not available. On admission, the subject presented with abnormal crying, vomiting (food), abdominal distension without bowel movements without fever. Abdominal z-ray was suggestive of intussusception with hydroaeric level. Abdominal ultrasound scan was also suggestive of intussusception at ileocaecal level and evidenced a mild peritoneal effusion. Intussusception was completely reduced by air enema. Clinical course was favourable and marked by a few rectorrhagia which resolved spontaneously. The subject resumed his normal feeding without pain with a normalization of bowel movement and a soft abdomen. The subject was discharged from hospital on 29 December 2010 with a prescription of paracetamol if needed. Brighton score was quoted at 1 by a scientific committee. At the time of reporting, the events were resolved. The reporter''s assessment was not provided.


VAERS ID: 451131 (history)  
Form: Version 1.0  
Age: 0.23  
Sex: Male  
Location: Foreign  
Vaccinated:2010-05-12
Onset:2010-11-11
   Days after vaccination:183
Submitted: 2012-03-05
   Days after onset:480
Entered: 2012-03-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS A20CA593A / 1 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH E29603 / 1 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA978A / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Barium enema, Intussusception, Small intestinal resection, Ultrasound abdomen abnormal, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Ileitis
Preexisting Conditions: Born at 40 weeks of amenorrhea (birth weight at 3.95 kg); Mixed feeding with diversified diet; No relevant medical history
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 11Nov2010, normal; Abdominal X-ray, 11Nov2010, with contrast ag; Ultrasound scan, 11Nov2010, suggestive of in
CDC Split Type: B0784817A

Write-up: This case was reported by a CRO during a prospective study and described the occurrence of intussusception in a 8-month-old subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject weighed 9.4 kg and measured 75 cm. He was born at 40 weeks of amenorrhea (birth weight 3.95 kg). He had mixed feeding with diversified diet. Within 15 days before the events, the subject had no infectious disease and did not received any medication. Concurrent vaccinations included a first dose of INFANRIXQUINTA (batch A20CA593A) and a first dose of PREVENAR (batch E29603) given on 12 May 2010 and a second dose of INFANRIXQUINTA (batch A20CA616A) given on 18 August 2010. On 12 May 2010, the subject received first doses of ROTARIX (batch A41CA978A, route unknown), of INFANRIXQUINTA and PREVENAR. First symptom occurred on 11 November 2010, about 6 months after administration of the first dose of ROTARIX. On that date, the subject was admitted to emergency unit with abdominal distension. Abdominal X-ray was normal. Ultrasound scan and abdominal X-ray with contrast agent were abnormal and suggestive of intussusception. At emergency unit, barium and water enemas were ineffective. The subject was hospitalized in pediatric surgery unit where a partial resection of small intestine (4 cm) was performed. Intussusception was localized at right ileocolic level. Anatomopathological examination was performed and confirmed the diagnosis of intussusception of small intestine and evidenced ulcerative lesions of adenovirus ileitis (non event). Clinical course was favourable, the subject was discharged from hospital on 20 November 2010. Brighton score was quoted at 1 by a scientific committee. At the time of reporting, the events were resolved. The reporter''s assessment were not provided.


VAERS ID: 451133 (history)  
Form: Version 1.0  
Age: 0.42  
Sex: Female  
Location: Foreign  
Vaccinated:2009-08-16
Onset:2009-09-25
   Days after vaccination:40
Submitted: 2012-03-05
   Days after onset:892
Entered: 2012-03-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA685A / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal mass, Anaemia, Apathy, Enema administration, Hepatosplenomegaly, Intussusception, Pallor, Shock, Ultrasound abdomen abnormal, Vomiting, X-ray abnormal
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Dementia (broad), Gastrointestinal obstruction (narrow), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (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? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Sodium ironedetate
Current Illness: Cow milk protein allergy
Preexisting Conditions: Born at 40 weeks of amenorrhea (birth weight 3.89 kg). Exclusively fed with formula feed
Allergies:
Diagnostic Lab Data: Abdominal x-ray, 25Sep2009, abdominal mass; Ultrasound scan, 25Sep2009, suggestive of in
CDC Split Type: B0784612A

Write-up: This case was reported by a CRO during a prospective study and described the occurrence of intussusception in a 6-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject weighed 6.525 kg and measured 63 cm. She was born at 40 weeks of amenorrhea (birth weight 3.89 kg). The subject was exclusively fed with formula feed. An allergy to cow milk protein was suspected. Within the 15 days before the events, the subject had no infectious disease and received a single dose of PERROSTRANE. Concurrent vaccinations included a first dose of PENTAVAC and a first dose of PREVENAR given on 25 May 2009, a second dose of PENTAVAC and one dose of tuberculosis vaccine (BCG SSI) given on 10 July 2009, a first dose of ROTARIX (batch A41CA758A) given on 13 July 2009 and a third dose of PENTAVAC and a second dose of PREVENAR given on 10 August 2009. On 16 August 2009, the subject received her second dose of ROTARIX (batch A41CA685A, route unknown). First symptoms occurred on 25 September 2009, about 40 days after administration of the second dose of ROTARIX. On that date, she was admitted to emergency unit them hospitalized in an other hospital. Report from emergency unit was not available. At admission in hospital, the subject presented with pallor, apathy, state of shock and vomiting (milk and bile). Abdominal x-ray which showed an abdominal mass and ultrasound scan were suggestive of intussusception. Intussusception was reduced with an air enema. The subject was discharged from hospital on 27 September 2009. On 28 September and 03 October 2009, the same symptoms recurred. Each time intussusception was reduced by air enema. Investigations about reported hepatosplenomegaly and anemia (nos) were in progress. Brighton score was quoted at 4 by a scientific committee. At the time of reporting, the events were resolved. The reporter''s assessment was not provided.


VAERS ID: 451135 (history)  
Form: Version 1.0  
Age: 0.32  
Sex: Male  
Location: Foreign  
Vaccinated:2008-06-06
Onset:2008-12-11
   Days after vaccination:188
Submitted: 2012-03-05
   Days after onset:1180
Entered: 2012-03-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR - / 2 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Apathy, Crying, Dehydration, Enema administration, Intussusception, Laparotomy, Pallor, Pyrexia, Rectal haemorrhage, Small intestinal resection, Ultrasound scan abnormal, Vomiting, Weight decreased
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FLUISEDAL; Betamethasone Na PO4; Paracetamol; OTIPAX
Current Illness: Cough
Preexisting Conditions: Prematurity; Mixed feeling with diversified diet. No relevant medical history.
Allergies:
Diagnostic Lab Data: Body temperature, 12Dec2008, $g38deg. Celsius; Ultrasound scan, 12Dec2008, suggestive of in
CDC Split Type: B0784495A

Write-up: This case was reported by a CRO during a prospective study and described the occurrence of intussusception in a 10-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject weighed 9 kg and measured 71 cm. He was a premature baby, born at 33 weeks of ameorrhea (birth weight 2.715 kg). He had mixed feeding with a diversified diet. He had no other relevant medical history. Concurrent vaccinations included a first dose of PENTAVAC, a first dose of PREVENAR and a first dose of ROTARIX given on 09 April 2008, a second dose of PENTAVAC given on 06 June 2008, a third dose of PENTAVAC and a second dose of PREVENAR given on 14 August 2008 and one dose of PRIORIX given on 08 October 2008. Within the 15 days before the event, the subject had cough and was treated with DOLIPRANE, CELESTENE, FLUISEDAL and OTIPAX. On 06 June 2008, the subject received his second dose of ROTARIX (batch and route unknown) and the second dose of PENTAVAC. First symptoms occurred on 11 December 2008, about 6 months after administration of last dose of ROTARIX. On 12 December 2008, the subject was admitted to emergency unit with abnormal crying, apathy, vomiting (food) and rectorrhagia. Ultrasound scan results was suggestive of intussusception. The subject was transferred in an other hospital. On admission pallor, fever (over 38 degrees Celsius), sign of dehydration and blood in nappy were reported. A weight loss of about 10 per cent was noticed. One air enema was ineffective. A partial resection of small intestine and ascending colon (25 cm) was performed and localized the intussusception in right ileo colic part of the small intestin with an idiopathic etiology. The subject was discharged from hospital on 22 December 2008. A post operative occlusion with relapse of intussusception was reported on 07 January 2009 treated by surgery with a new laparotomy. Brighton score was quoted at 1 by a scientific committee. At the time of reporting, the events were resolved. The reporter''s assessment were not provided.


VAERS ID: 451136 (history)  
Form: Version 1.0  
Age: 0.15  
Sex: Male  
Location: Foreign  
Vaccinated:2008-11-26
Onset:2008-12-21
   Days after vaccination:25
Submitted: 2012-03-05
   Days after onset:1170
Entered: 2012-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Crying, Diet refusal, Drug administered to patient of inappropriate age, Intussusception, Pallor, Ultrasound abdomen abnormal
SMQs:, Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Skin eruption
Preexisting Conditions: Born at 41 weeks of amenorrhea, birth weight 3 kg. Bottle feeding without diversified diet. No relevant medical history.
Allergies:
Diagnostic Lab Data: Ultrasound scan, 22Dec2008, suggestive of in
CDC Split Type: B0784532A

Write-up: This case was reported by a CRO during a prospective study and described the occurrence of intussusception in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject weighed 5.54 kg and measured 59 cm. He was born at 41 weeks of amenorrhea (birth weight 3 kg). He had bottle feeding without diversified diet. Within the 15 days before the events, the subject had a skin eruption but did not received any treatment. Concurrent vaccinations included a first dose of INFANRIX HEXA (administered before 8-week-old so maladministration child to young) and a first dose of PREVENAR given on 26 November 2008. On 26 November 2008, the subject received his first dose of ROTARIX (batch and route unknown), of INFANRIX HEXA and of PREVENAR. First symptoms occurred on 21 December 2008, about 25 days after administration of the first dose of ROTARIX. On 22 December 2008, the subject was admitted to emergency unit with abnormal crying, pallor and refusal to eat. Ultrasound scan results was suggestive of intussusception. The subject was hospitalized in pediatric surgery unit, abdominal distension was evidenced. No enema or surgery was made. Clinical course was favourable. The subject was discharged from hospital on 24 December 2008. Brighton score was quoted at 4 by a scientific committee. At the time of reporting, the events were resolved. The reporter''s assessment was not provided.


VAERS ID: 451173 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Male  
Location: Foreign  
Vaccinated:2009-04-27
Onset:2009-06-16
   Days after vaccination:50
Submitted: 2012-03-06
   Days after onset:994
Entered: 2012-03-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Apathy, Crying, Diet refusal, Enema administration, Intussusception, Pallor, Tenderness, Ultrasound scan abnormal
SMQs:, Dementia (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (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, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Born at 40 weeks of amenorrhea (birth weight 3.52 kg); Exclusively fed with formula feed; No relevant medical history
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0784587A

Write-up: This case was reported by a CRO during a prospective study and described the occurrence of intussusception in a 6-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject weighed 7.5 kg and measured 67 cm. He was born at 40 weeks of amenorrhea (birth weight 3.52 kg). The subject was exclusively fed with formula feed and had no relevant medical history. Within the 15 days before the events, the subject had no infectious disease and received no treatment. Concurrent vaccinations included a first dose of INFANRIX HEXA and a first dose of PREVENAR given on 15 January 2009, a first dose of ROTARIX and a second dose of PENTAVAC given on 17 February 2009 and a third dose of INFANRIX HEXA and a second dose of PREVENAR given on 20 March 2009. On 27 April 2009, the subject received his second dose of ROTARIX (batch and route unknown). First symptoms occurred on 16 June 2009, about 50 days after administration of the second dose of ROTARIX. On that date, the subject was admitted to emergency unit then hospitalized. Report from emergency unit was not available. On admission, the subject presented with abnormal crying, pallor, apathy, refusal to eat and pain on palpation. Results of ultrasound scan were suggestive of intussusception. The intussusception was reduced with water enema. Clinical course was favourable, the subject was discharged from hospital on 17 June 2009. Brighton score was quoted at 1 by a scientific committee. At the time of reporting, the events were resolved. The reporter''s assessment were not provided.


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