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Found 564 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: 309285 (history)  
Form: Version 1.0  
Age: 0.5  
Gender: Male  
Location: Foreign  
Vaccinated:2008-02-16
Onset:2008-03-15
   Days after vaccination:28
Submitted: 2008-04-10
   Days after onset:26
Entered: 2008-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal pain, Appendicectomy, Body temperature increased, Crying, Gastrointestinal hypermotility, Haematochezia, Intussusception, Pyrexia, Surgery, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (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, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 15Mar2008, See text; Body temperature, 15Mar2008, 38deg. C
CDC Split Type: B0515484A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 6-month-old male subject who was vaccinated with Rotarix (GlaxoSmithKline). The subject had no relevant medical history or allergies. Previous vaccination included Rotarix (GlaxoSmithKline; oral) given on 26 October 2007. On 16 February 2008, the subject received the 2nd dose of Rotarix (oral). On March 15 2008, 28 days after vaccination with the 2nd dose of Rotarix, the subject experienced repeated vomiting (20 episodes/24H), some gastro-bilar vomiting, fever (38 deg. C) and fresh bloody stools (2). The subject was taken to the emergency room. The subject was hospitalised. Physical exam reported continuous crying, distended abdomen, painful to deep examination and hyperactive peristalsis. Abdominal X-ray was performed and showed distended loops with abnormal gas distribution. On 15 March 2008, ileocecal intussusception was confirmed by surgery and was resolved by taxis. Appendectomy was done. The subject was treated with cefotaxime, amikacin, Metamizol and Ketorolac. The subject evolved to clinical improvement and he was discharged on 19 March 2008 in good conditions. On 19 March 2008, the events were resolved. The physician considered the events were unrelated to vaccination with Rotarix.


VAERS ID: 309526 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2007-08-07
Onset:2007-11-21
   Days after vaccination:106
Submitted: 2008-04-15
   Days after onset:145
Entered: 2008-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abnormal faeces, Anastomotic complication, Appendicectomy, Blood albumin decreased, Blood calcium decreased, Blood glucose increased, Blood potassium decreased, Blood sodium decreased, Death, Gastrointestinal necrosis, Globulins decreased, Haematochezia, Haematocrit normal, Haemoglobin normal, Ileostomy, Intestinal anastomosis, Intestinal fistula, Intestinal perforation, Intussusception, Pallor, Parenteral nutrition, Peritonitis, Platelet count decreased, Protein total decreased, Pyrexia, Sepsis, Surgery, Vomiting, White blood cell count decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Agranulocytosis (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal perforation (narrow), Gastrointestinal haemorrhage (narrow), Biliary system related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Ischaemic colitis (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Noninfectious diarrhoea (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-03-14
   Days after onset: 113
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 25Nov2007, see textunit; Albumin, 29Nov2007, 2.2g/dl; Blood glucose, 29Nov2007, 148mg/dl; Calcium, 29Nov2007, 7.0mg/dl; Globulin, 29Nov2007, 1.0g/dl; Hematocrit, 29Nov2007, 34%; Hemoglobin, 29Nov2007, 11.4g/dl; Leukocyte count NOS, 29Nov2007, 4720mm3; Platelet count, 29Nov2007, 152000mm3; Potassium, 29Nov2007, 2.8mEg/l; Protein total, 29Nov2007, 3.2g/dl; Sodium, 29Nov2007, 117mEg/l
CDC Split Type: B0515998A

Write-up: This case was reported by a physician in a frame of a study and described the occurrence of ileocolic intussusception in a 10-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). When the events started the subject was 6-month-old. On 7 August 2007 the subject received 1st dose of ROTARIX (oral). The 2nd dose schedule which should be given on 07 October 2007 was discontinued. The subject was on no other medication and had no relevant medical history nor allergy. On 21 November 2007, 106 days after vaccination with ROTARIX, the subject presented bloody stool (6-8 times/day), vomiting (6 times/day) and fever. On 25 November the subject was brought to hospital. Subject''s physical examination showed pallor, jelly red stools and abdominal distention. Abdominal x-ray showed distended intestinal loops. The same day the subject underwent a surgery. Intussusception was confirmed and resolved. Also ileostomy (20cm) was performed due to ileal necrosis and prophylactic appendectomy. On 29 November 2007 the subject was transferred to another hospital in bad conditions with persisting bloody stools and abdominal distention. Therefore a 2nd surgery was performed finding generalised peritonitis due to 3 intestinal perforation, 3-termino anastomosis were done. On 03 December 2007 a 3rd surgery was done due to opened anastomosis. On 06 December 2007 the 4th surgery was performed due to intestinal fistula. The subject was treated with total parenteral nutrition due to short intestine syndrome. The subject evolution was bad. The subject was hospitalised and the physician considered the events were disabling and life threatening. The subject was treated with AMPICILLIN, amikacin, clindamycin, metronidazole, Ranitidine, methimazole. The physician considered the events were unrelated to vaccination with ROTARIX. The subject died on 14 March 2008 from sepsis. An autopsy was not performed.


VAERS ID: 309529 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2007-12-31
Onset:2008-01-19
   Days after vaccination:19
Submitted: 2008-04-15
   Days after onset:86
Entered: 2008-04-15
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 - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal pain, Abnormal faeces, Aspiration biopsy, Band neutrophil percentage increased, Barium double contrast, Enema administration, Haematochezia, Hypertrophy, Intussusception, Lymphocyte percentage decreased, Neutrophil percentage increased, Occult blood positive, Peristalsis visible, Platelet count increased, Vomiting, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Biliary system related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 20Jan2008, Abnormalunit; Air contrast barium enema, 20Jan2008, Invaginationunit; Aspiration biopsy, 20Jan2008, Negativeunit; Band neutrophil percentage, 20Jan2008, 6%; Fecal occult blood, 20Jan2008, positiveunit; Lymphocytes, 20Jan2008, 18%; Neutrophils, 20Jan2008, 71%; Platelet count, 20Jan2008, 820000/mm3; White blood cells, 20Jan2008, 23800/mm3
CDC Split Type: B0508483A

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 DTaP + IPV + Hib; manufacturer unspecified; intramuscular; given on 30 October 2007 and on 31 December 2007; Hep B; manufacturer unspecified; intramuscular; given on 2 September 2007 and on 30 October 2007; Rotarix; GlaxoSmithKline; oral given on 30 October 2007; tuberculosis vaccine; manufacturer unspecified; intradermal; given on 2 September 2007. On 31 December 2007, the subject received 2nd dose of Rotarix (oral), lot number not provided. On 19 January 2008, 19 days after vaccination with Rotarix, the subject experienced one bloody stool. On 20 January 2008, he experienced 3 times vomiting. The subject was brought to emergency ward. At examination, abdominal pain with normal peristalsis was found. He experienced current jelly stool and intussusception was suspected. The laboratory tests showed white blood cell 23800/mm3, neutrophils 71%, neutrophil band 6%, lymphocytes 18%, platelets 820000/mm3. The fecal occult blood test was positive whereas the fine needle aspiration biopsy was negative. Abdominal X-ray showed air fluid level with distal gas. The diagnosis of intussusception was confirmed by the barium air enema. The subject was hospitalised and the physician considered the events were life threatening and clinically significant (or requiring intervention). On 20 January 2008, surgery was performed and ileocolic intussusception of 20 cm was found as well as Peyer plaques hypertrophy. The intussusception was reduced without complication. No resection was performed. On 23 January 2008, the events were resolved. The subject was discharged from hospital on 25 January 2008 in good clinical condition. The physician considered the events were possibly related to vaccination with Rotarix. Follow-up received on 9 April 2008: The events were resolved on 25 January 2008.


VAERS ID: 310110 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Foreign  
Vaccinated:2007-11-18
Onset:2008-03-01
   Days after vaccination:104
Submitted: 2008-04-18
   Days after onset:47
Entered: 2008-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal pain, Anal haemorrhage, Dehydration, Haematochezia, Inappropriate schedule of drug administration, Intussusception, Irritability, Pain, Pallor, Peristalsis visible, Pyrexia, Surgery, Ultrasound abdomen abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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), Hypotonic-hyporesponsive episode (broad), Medication errors (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 03Mar2008, see textunit; Ultrasound abdomen, 04Mar2008, see textunit
CDC Split Type: B0516401A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 5-month-old male subject who was vaccinated with Rotarix (GlaxoSmithKline). Previous and/or concurrent vaccination included Pentavac; manufacturer unspecified;intramuscular given on 18 November 2007 and 3 February 2008; hepatitis B; manufacturer unspecified; intramuscular given on 12 September 2007; pneumococcal vaccine, unspecified; manufacturer unspecified; intramuscular given on 18 November 2007 and 3 January 2008; tuberculosis vaccine; manufacturer unspecified; intradermal given on 12 September 2007. On 18 November 2007 the subject received 1st dose of Rotarix (oral). On 1 March 2008, 104 days after vaccination with Rotarix, the subject presented vomiting (6 times), fever and irritability. Two days after he presented bloody stools and abdominal distention. The subject required hospitalisation. He had abdominal bloating, with pain, decreased and distended peristalsis, pallor, dehydration and blood in anus. On 03 March 2008 abdominal x-ray was performed which showed absence of air, interloop edema and absence of air on pelvic fossa. On 04 April 2008 abdominal ultrasound showed free fluid on cavity and loops with air and abundant fluids. On 05 March 2008 the subject underwent a surgery which corroborated ileocolic intussusception. Intussusception was reduced by taxis without complications. Mesenteric nodes for biopsy was taken for further investigation but the results were unknown. Post surgical evolution was favorable. On 10 March 2008 the subject was discharged. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). The subject was treated with Ampicillin, Amikacin and surgery. The physician considered the events were unrelated to vaccination with Rotarix.


VAERS ID: 310113 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Foreign  
Vaccinated:2008-04-02
Onset:2008-04-06
   Days after vaccination:4
Submitted: 2008-04-18
   Days after onset:12
Entered: 2008-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (TRITANRIX) / GLAXOSMITHKLINE BIOLOGICALS AT15B8338A / UNK RL / UN
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS A72CA204A / UNK RL / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA447B / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Abdominal pain, Anuria, Catheter placement, Computerised tomogram abnormal, Crystal urine, Enema administration, Intestinal resection, Intussusception, Surgery, Ultrasound abdomen abnormal, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (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), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: CT scan, 06Apr2008, intussusceptunit; Ultrasound abdomen, 06Apr2008, intussusceptunit
CDC Split Type: b0516016A

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). Previous and/or concurrent vaccination included Hiberix; GlaxoSmithKline; right thigh given on 18 February 2008 and 2 April 2008; Tritanrix; GlaxoSmithKline; right thigh given on 18 February 2008 and 2 April 2008; oral poliomyelitis vaccine; non-GSK manufacturer; oral given on 18 February 2008. On 2 April 2008, the subject received 1st dose of Rotarix (oral). On 6 April 2008, 4 days after vaccination with Rotarix, the subject experienced abdominal cramp with vomiting. The subject was brought to hospital where the clinical examination showed a distended abdomen. Abdomen ultrasound and CT scan revealed an intussusception. Water enema was performed twice without success. The subject was hospitalised. On 7 April 2008, at surgery, an ileocolic intussusception was found and bowel resection was performed. After surgery, the subject experienced anuria with urinary crystals following catheter in bladder. He was readmitted to hospital for a bladder washout. At the time of reporting the outcome of the events was unspecified.


VAERS ID: 311018 (history)  
Form: Version 1.0  
Age: 0.5  
Gender: Female  
Location: Foreign  
Vaccinated:2008-04-03
Onset:2008-04-04
   Days after vaccination:1
Submitted: 2008-04-25
   Days after onset:21
Entered: 2008-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal pain, Blood creatinine increased, Blood glucose normal, Blood thromboplastin, Dehydration, Gastrointestinal sounds abnormal, Haematochezia, Haemoglobin normal, Hyperaemia, Intussusception, Malaise, Mucous stools, Oral intake reduced, Pallor, Pharyngeal erythema, Platelet count increased, Prothrombin time prolonged, Pyrexia, Surgery, Upper respiratory tract infection, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Liver-related coagulation and bleeding disturbances (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray 10Apr2008 see text unit; Blood glucose 10Apr2008 107mg/dl; Creatinine 10Apr2008 0.5mg/dl; Hemoglobin 10Apr2008 12.8g/dl; Platelet count 10Apr2008 618000mm3; Prothrombin time 10Apr2008 12.7s; Thromboplastin 10Apr2008 42.3s
CDC Split Type: B0517189A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 5-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included live attenuated human rotavirus vaccine (GlaxoSmithKline, oral) given on 22 February 2008; pneumococcal vaccine, unspecified (manufacturer unspecified, intramuscular) given on 3 April 2008. On 3 April 2008 the subject received 2nd dose of ROTARIX (oral). On 4 April 2008, 1 day after vaccination with ROTARIX, the subject presented upper respiratory tract infection not specified and characterised by fever, vomiting and not oral acceptance. The subject was treated with Paracetamol and Ampicillin without improvement. On 7 April 2008, the subject continued with vomiting and fever. On 10 April 2008 the subject was brought to the emergency room with persisting fever, vomiting and mucosanguinolent stool. at physical examination he showed dehydration, malaise, pallor, pharyngeal hyperemia, abdominal pain timpanic and distended, absent bowel sound and rectal tract with evidence of current jelly stools. Relevant test results included abdominal x-ray which showed suggestive image of intussusception, dilated small bowel and lack of air in distal colon. Therefore the same day the subject underwent a surgery. Ileocecal intussusception was found without complications in intestinal loops, only reduction by taxis was done. After that the subject''s clinical condition was favorable. On 15 April 2008 the subject was discharged. The physician considered the events were possibly related to vaccination with ROTARIX.


VAERS ID: 311022 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:2008-01-23
Onset:0000-00-00
Submitted: 2008-04-25
Entered: 2008-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / ID
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / ID
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / ID
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK 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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0516402A

Write-up: This case was reported by a physician and described the occurrence of invagination of intestine in a 3-month-old female subject who was vaccinated with Rotarix (GlaxoSmithKline). The subject had no family history of intussusception or bowel abnormalities. The subject had no history of the following: congenital intestinal malformation, intestinal polyps, Merckel''s diverticulum, intestinal vascular malformations, cystic fibrosis, Hirschsprung disease, other gastrointestinal malformation and dysfunction. Previous vaccination included tuberculosis vaccine (manufacturer unspecified; oral) given on 18 November 2007. Concurrent vaccination included DTaP, HIB (manufacturer unspecified; intradermal; unknown) given on 23 January 2008 and hepatitis B vaccine recombinant (manufacturer unspecified; intramuscular; unknown) given on 23 January 2006. On 23 January 2008, the subject received the 1st dose of Rotarix (oral). On unspecified date, at unspecified time after vaccination with the 1st dose of Rotarix, the subject experienced intestinal invagination. On 29 February 2008, a reduction of intestinal invagination was performed in hospital and was without complications. The subject was discharged with good conditions; however she needed to go to the same hospital on 05 March 2008 with similar symptoms. The subject was hospitalised and the physician considered the event was clinically significant (or requiring intervention). Plain abdominal radiograph, abdominal ultrasound and abdominal CT were not performed. On 05 March 2008, the subject required again an intervention. Finding: interstinal invagination, corroborating on second surgery type colo-colic-cecolic, reduction was performed without complications. The subject did not have a bowel resection. The subject was transferred to another hospital on 10 March 2008 to continue with surveillance. The subject was stable, abdomen was tender and she was without evidence of post-surgery complications. She presented good oral tolerance, normal evacuations and she was without notice of infection disease. She was discharged with good response on 12 March 2008. On 12 March 2008, the event was resolved. The physician considered the event was unrelated to vaccination with Rotarix.


VAERS ID: 311250 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2007-12-11
Onset:2008-01-09
   Days after vaccination:29
Submitted: 2008-04-29
   Days after onset:110
Entered: 2008-04-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPH: DTAP + HIB (TRIHIBIT) / SANOFI PASTEUR - / UNK UN / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood pressure, Enema administration, Fatigue, Haematochezia, Heart rate, Intussusception, Irritability, Pain, Ultrasound scan abnormal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), 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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TIORFAN (ACETORPHAN), unknown, 08-Jan-2008; Advil (IBUPROFEN), unknown, 08-Jan-2008; DOLIPRANE (PARACETAMOL), unknown, 08-Jan-08
Current Illness: A concurrent history of gastroenteritis manifested by 10 liquid, glary and bloody stools per day, vomiting, fever at 38.7 C and weight loss of 4%, began on 08-Jan-2008 whereas members of her family had gastroenteritis. She was started on Tiorfan, Advil, Doliprane solution for rehydration.
Preexisting Conditions: The patient had a past history of normal full-term newborn, a medical history of unspecified reflux, no history of allergy.
Allergies:
Diagnostic Lab Data: On 09-Jan-2008 test results were: ultrasound scan (results: acute intestinal intussusception suspected); heart rate (results: 156/min); and blood pressure (results: 107/77).
CDC Split Type: FRWYEG01473408

Write-up: Information regarding PREVENAR was received from a healthcare professional regarding a 4-month-old female patient who experienced acute intestinal intussusception. The patient received the second dose on 11-Dec-2007. On 09-Jan-2008, the patient was admitted to emergency unit due to pain and blood in stools. On admission the patient was tired and irritable. Physical examination was unremarkable, she had no fever and no sign of dehydration. Acute intestinal intussusception was suspected on ultrasound scan. The patient was hospitalized and intussusception was reduced with water-soluble enema. The patient recovered without sequelae. No additional information was available at the time of this report.


VAERS ID: 311332 (history)  
Form: Version 1.0  
Age: 0.6  
Gender: Female  
Location: Foreign  
Vaccinated:2007-10-01
Onset:2008-02-12
   Days after vaccination:134
Submitted: 2008-04-30
   Days after onset:77
Entered: 2008-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / IM
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal pain, Appendicectomy, Crying, Dehydration, Gastrointestinal hypermotility, Haematochezia, Inappropriate schedule of drug administration, Intussusception, Irritability, Surgery, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (narrow), Medication errors (narrow), 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: Abdominal X-ray 14Feb2008 Abnormal unit
CDC Split Type: B0517193A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 11-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine; manufacturer unspecified; intramuscular; given on 31 July 2007, 4 December 2007 and an unspecified date; hepatitis B vaccine recombinant; manufacturer unspecified; intramuscular; given on 31 July 2007, 1 October 2007 and 4 December 2007; influenza virus vaccine; manufacturer unspecified; intramuscular; given on 4 December 2007; live attenuated human rotavirus vaccine; GlaxoSmithKline; oral given on 31 July 2007; pneumococcal vaccine, unspecified; manufacturer unspecified; intramuscular; given on 31 July 2007 and 1 October 2007; tuberculosis vaccine; manufacturer unspecified; intradermal; given on 9 February 2008. On 1 October 2007, the subject received 2nd dose of ROTARIX (oral), lot number not provided. On 12 February 2008, 4 months after vaccination with ROTARIX, the subject experienced gastric vomiting followed by biliary vomiting with colic and abdominal pain. She had not flatulence nor fever. On 13 February 2008, the subject was hospitalised for 7 days. Physical examination showed abdominal pain with increased peristalsis, dehydration, irritability, crying at abdominal palpation, non-tender abdomen with respiratory pathology. On 14 February 2008, the subject experienced bloody stools as well as biliary vomiting. The rectal examination revealed an empty ampulla with blood. Abdomen X-ray showed fluid levels and dilated bowel loops with non-specific abnormalities. No intussusception was found. The surgery was performed and intussusception of ascending and descending colon was found and resolved by taxis without complication. A prophylactic appendectomy was performed. On 19 February 2008, the events were resolved and the subject was discharged from hospital in good clinical condition. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 311333 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Female  
Location: Foreign  
Vaccinated:2008-04-10
Onset:2008-04-16
   Days after vaccination:6
Submitted: 2008-04-30
   Days after onset:14
Entered: 2008-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Intestinal obstruction, Intussusception, Surgery, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0517644A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 5-month-old female subject who was vaccinated with Rotarix (GlaxoSmithKline). No concomitant medication was given to the subject. On 10 April 2008, the subject received unspecified dose of Rotarix (oral), lot number not provided. On 16 April 2008, 6 days after vaccination with Rotarix, the subject experienced abdominal distension and vomiting. On 18 April 2008, the subject was hospitalised. The exam performed showed intestinal obstruction. A surgery was performed and intussusception was found. The physician considered the events were life threatening and clinically significant (or requiring intervention). At the time of reporting the events were improved.


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