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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: 421947 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Unknown  
Location: Foreign  
Vaccinated:2011-01-18
Onset:2011-01-24
   Days after vaccination:6
Submitted: 2011-04-29
   Days after onset:94
Entered: 2011-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB139A / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal discomfort, Abdominal distension, Acute abdomen, Ascites, C-reactive protein, Crying, Diet refusal, Endotracheal intubation, Enema administration, Faeces discoloured, Fatigue, Gastrointestinal disorder, Gastrointestinal inflammation, Gastrointestinal necrosis, General anaesthesia, Haematochezia, Ileitis, Ileus, Intestinal ischaemia, Intussusception, Laparoscopy, Laparotomy, Microscopy, Mucous stools, Nodule, Pain, Restlessness, Small intestinal anastomosis, Small intestinal intussusception reduction, Soft tissue haemorrhage, Ultrasound abdomen abnormal, Volvulus, Vomiting
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Akathisia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (broad), Respiratory failure (broad), 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, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: C-reactive protein, 31Jan2011, 5ng/dL; Laparoscopy, 25Jan2011, See text; Ultrasound abdomen, 25Jan2011, See text; Ultrasound abdomen, 26Jan2011, See text
CDC Split Type: B0699795A

Write-up: This case was reported by a physician via a representative and described the occurrence of intussusception in a 8-week-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). In January 2011, the subject received 1st dose of ROTARIX (route unknown, batch number not provided). In 2011, less than one month after vaccination with ROTARIX, the subject experienced intussusception. The subject was hospitalised. The subject was treated with surgery. At the time of reporting, the outcome of the event was unspecified. It''s decided to not administrate the 2nd dose of ROTARIX. Follow-up information received on 15 April 2011: The medical history did not include any known history of intussusceptions or bowel abnormalities, any previous intra-abdominal surgery, any intestinal polyps, Meckels diverticulum, intestinal vascular malformations, cystic fibrosis, Hirschsprung disease, any other gastrointestinal malformation and any intussusception. Concurrent vaccination included combined diphtheria, tetanus-acellular pertussis, hepatitis B, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (GlaxoSmithKline; route and injection site unknown) given on 18 January 2011 and pneumococcal vaccines (Wyeth Labs; route and injection site unknown) given on 18 January 2011. On 18 January 2011 the subject received 1st dose of ROTARIX (oral). on 24 January 2011, 6 days after vaccination with ROTARIX, the subject did not drink, was washed-out, was washed-out and experienced pain, restlessness and cru high. Acute abdomen was developed. On 25 January 2011, 7 days after vaccination with ROTARIX, the subject experienced vomiting after drinking bottle, dark stool, was still washed-out with pain. The subject was hospitalised for 9 days and the physician considered the events were clinically significant (or requiring intervention). An abdomen ultrasound was performed and showed suspected intussusceptions. The subject was quiet with normal stool, no vomiting and no fever. On 26 January 2011, 8 days after vaccination with ROTARIX, the subject presented mucous bloody stool and vomiting. A new abdomen ultrasound was performed and showed a lot of fluid with suspect image of torsion volvulus but the intussusception was not clearly visible. An emergency laparoscopy took place. The subject was treated with surgery under general anesthesia because of swollen and irritated abdomen: laparoscopy given the massive distension of the small intestine, a further laparoscopic exploration was not possible. It was converted to laparotomy with which such an invagination (based on multiple nodes) was found. This was reduced with no defects but the last ileal loop only moderately recuperated and held a thickened wall that allowed passage with difficulty. It was decided to resect that segment over about 7 centimeters and Ileo-ileal (end to end) anastomosis was applied. The subject underwent an endotracheal intubation. The macroscopy [Due to memory limitations, the remainder of this text could not be compared.] copy examination showed the following findings: About the terminal ileum after intussusceptions: 2F of 4g in total. Two intestinal segments of 4 cm and 0.6 cm with diameter 1.4 cm. No perforations visible. Serosa is not covered with fibrin. 3 transverse cuts in C2 (rest). About the transluminal nodule: 1 intestinal segment with length of 1.9 cm and 1.5 cm diameter. 3 transverse cuts in C2 (rest). About the appendix: 4.8 cm length and 0.5 cm diameter. Macroscopically no abnormalities. C3 (rest). The microscopy examination showed following findings: About the terminal ileum after intussuceptions: preparations show cuts through an ileal wall that is mostly or entirely necrotised. There is acute ischemia and transmural hyperemia and necrosis. About the transluminal nodule: This nodule consists of hyperemic necrotic bowel tissue. About the appendix: The mucosa is lined with cylindric cells and mucinous goblet Cells; it shows no ulceration. The crypt of lieberkuhn are lined with cylindric cells en mucinous goblet cells. Propria is infiltrated with lymphocytes, plasmocytes and a few eosinophiles. Lymphoid system of the submucosa is normally developed. We can see germinal centers surrounded by small lymphocytes. The connective tissue of submucosa is loose and not infiltrated. Both layers of the tunica muscularis were regular. They are not infiltrated. Serosa showed fat cells, connective tissue and vessels. We see no leucocytes infiltration; mesothelial lining is normal. Conclusion: the terminal ileum after invagination showed acute ischemic ileitis and the transluminal nodule was necrotic with hemorrhagic intestinal tissue. No plain abdominal radiograph/air or liquid contrast enema and no abdominal computerised tomography were performed. The subject was not treated by liquid contrast/hydrostatic water/air enema and there were no complication of surgery. On 27 January 2011, there was still significant ileus, with vomiting when restarting the food. Since 31 January 2011, the events were resolved: food could easily be restarted and there was easy bowel evacuation, there were no problem with the transit. The inflammatory parameters decreased progressively under AUGMENTIN to a C-reactive protein of 5 ng/dl. The clinical condition improved gradually. On 2 February 2011, the subject could leave the hospital in good general condition: the weight was increasing. The wound healing did not cause problem. There have been no episodes of fever. At clinical examination, the abdomen was flexible, not swollen, and the wound healed well and is tight. The physician considered the events were possibly related to vaccination with ROTARIX.


VAERS ID: 421949 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2010-12-23
Onset:2010-12-28
   Days after vaccination:5
Submitted: 2011-04-29
   Days after onset:121
Entered: 2011-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal mass, Blood culture, Culture wound negative, Decreased appetite, Dyspnoea, Excessive granulation tissue, Haematochezia, Intussusception, Lymphadenitis, Pallor, Postoperative wound infection, Respiratory syncytial virus bronchiolitis, Scar, Shock, Ultrasound scan abnormal, Urine analysis normal, Vomiting, Wound secretion
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), 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), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Cardiomyopathy (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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 16 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Culture wound, Jan2011, see text; Diagnostic ultrasound, 28Dec2010, intussusception; Hemoculture, Jan2011, sterile; Urine analysis, Jan2011, microchemical ne
CDC Split Type: B0714558A

Write-up: This case was reported by a regulatory authority (DHH-N2011-55389) and described the occurrence of intussusception in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 23 December 2010, the subject received 1st dose of ROTARIX (oral, batch number not provided). On 27 December 2010, 4 days after vaccination with ROTARIX, the subject experienced anorexia. On 28 December 2010, 5 days after vaccination with ROTARIX, the subject experienced intermittent vomiting, pallor and shock. On palpation, the abdomen was supple but on the right, there was a difficult to delineate mass that could be perceived. On palpation per anum, there was evacuation of bloody stools. Intussusception was clinically diagnosed and confirmed by ultrasound. An immediate surgical reduction was performed. This was successful and no resection of the intestinal segments was done. The subject was hospitalised on 28 December 2010 and the regulatory authority reported that the events were life threatening. The subject was kept sober during 24 hours and afterwards, nutramigen was started. On 2 January 2011, Beba was inserted. A control ultrasound after the surgery only gave an image of adenitis but no intussusception anymore. The subject was treated with antibiotics IV during 5 days and afterwards with clamoxyl during one week. On 6 January 2011, 14 days after vaccination with ROTARIX, the subject was again hospitalised due to a wound infection after the surgery. Despite the treatment with CLAMOXYL, there was a clear fluctuation and approximately 10cc pus was evacuated on spontaneous eruption. The wound was taken care of locally and once let it close, secondarily granulated. The subject had also problem breathing and respiratory syncytial virus bronchiolitis. Several tests were performed: microchemical urine: negative, hemoculture: sterile and wound culture. The subject was treated with AUGMENTIN, oxygen and ISOBETADINE. The subject was discharged on 12 January 2011 with CLAMOXYL and aerosol during one week. The subject was seen back weekly amongst by the department surgery. At the time of reporting, the events were resolved with following sequelae: retracted scar (observed on 17 February 2011). The vaccination course with ROTARIX was discontinued.


VAERS ID: 422672 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Foreign  
Vaccinated:2011-03-26
Onset:2011-03-30
   Days after vaccination:4
Submitted: 2011-05-11
   Days after onset:42
Entered: 2011-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, General physical health deterioration, Intussusception
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? 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: B0717125A

Write-up: This case was reported by a physician via a sales representative and described the occurrence of intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 26 March 2011, the subject received unspecified dose of ROTARIX (unknown route, unknown lot number). On 30 March 2011, 4 days after vaccination with ROTARIX, the subject experienced intussusception, abdominal pain and general state alteration. This case was assessed as medically serious by GSK. The subject was treated with Rehydration and Probiotics. The subject was better after 48 hours. At the time of reporting the events were resolved. The physician considered the events were almost certainly related to vaccination with ROTARIX.


VAERS ID: 422811 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2010-03-02
Onset:2010-05-18
   Days after vaccination:77
Submitted: 2011-05-12
   Days after onset:359
Entered: 2011-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS XROLA084A1 / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Intussusception, Rectal haemorrhage, Surgery, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: B0718459A

Write-up: This case was reported by a healthcare professional via another manufacturer and described the occurrence of intussusception in a 6-month-old male subject who was vaccinated with ROTARIX (Fiocruz). On 2 March 2010, the subject received 1st dose of ROTARIX (oral). On 18 May 2010, 77 days after vaccination with ROTARIX, the subject experienced intussusception, rectal bleeding, vomiting and abdominal distension. The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with surgery. At the time of reporting the events were resolved.


VAERS ID: 422812 (history)  
Form: Version 1.0  
Age: 1.08  
Sex: Female  
Location: Foreign  
Vaccinated:2010-05-17
Onset:2010-06-03
   Days after vaccination:17
Submitted: 2011-05-12
   Days after onset:343
Entered: 2011-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS XROLA081B1 / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Abdominal pain, Appendicectomy, Haematochezia, Intestinal dilatation, Intussusception, Lethargy, Surgery, Ultrasound abdomen abnormal, Vomiting, X-ray gastrointestinal tract abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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: Ultrasound abdomen, 03Jun2010, intussusception; X-ray, 03Jun2010, bowel distension
CDC Split Type: B0718458A

Write-up: This case was reported by a healthcare professional via another manufacturer and described the occurrence of intussusception in a 13-month-old female subject who was vaccinated with ROTARIX (Fiocruz). Previous and/or concurrent vaccination included combined diphtheria, tetanus, pertussis (A or W not known) and haemophilus influenzae type b vaccine; manufacturer unspecified; unknown; unknown given on 17 May 2010; live attenuated oral poliomyelitis vaccine; manufacturer unspecified; unknown; unknown given on 17 May 2010. On 17 May 2010, the subject received 2nd dose of ROTARIX (oral). On 3 June 2010, 17 days after vaccination with ROTARIX, the subject experienced intussusception, bloody stools, lethargy, abdominal distension, bilious vomit and abdominal pain. The subject was hospitalised and the healthcare professional considered the events were disabling. The x-ray suggested a bowel distension and abdominal ultrasound showed left flank and iliac fossa intussusception with cavity fluid. The subject was treated with surgery (surgical reduction) and appendicectomy without resection. At the time of reporting, the events were resolved.


VAERS ID: 422813 (history)  
Form: Version 1.0  
Age: 0.44  
Sex: Unknown  
Location: Foreign  
Vaccinated:2010-07-12
Onset:2010-07-15
   Days after vaccination:3
Submitted: 2011-05-12
   Days after onset:301
Entered: 2011-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPH: DTAP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS XROLA102A1 / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Anaemia, Arrhythmia, Cardiogenic shock, Death, Fatigue, Gastrointestinal surgery, Haematochezia, Hepatic failure, Insomnia, Intussusception, Pyrexia, Septic shock, Vomiting
SMQs:, Cardiac failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Toxic-septic shock conditions (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-07-17
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0718451A

Write-up: This case was reported by a healthcare professional via another manufacturer (Fiocruz) and described the occurrence of intussusception in a 5-month-old subject of unspecified gender who was vaccinated with ROTARIX (Fiocruz). Concurrent vaccination included combined diphtheria, tetanus, acellular pertussis and Haemophilus influenzae type b vaccine (manufacturer unspecified, unknown route of administration) and live attenuated oral poliomyelitis vaccine (manufacturer unspecified, oral), given on 12 July 2010. On 12 July 2010, the subject received also 2nd dose of ROTARIX (oral). On 15 July 2010, 3 days after vaccination with ROTARIX, the subject experienced vomiting (first symptoms of intussusception). The subject was hospitalised for vomiting. On 16 July 2010, in the morning, the subject was discharged but was hospitalised again later in the day due to experience of insomnia and bloody stool. In the evening, the subject underwent a surgical reduction of bowels. On 17 July 2010, by dawn, the subject experienced high fever (unknown body temperature), tiredness and arrhythmia. The subject died on 17 July 2010 from anemia (onset unspecified), cardiogenic shock, intussusception (primary cause of death), liver failure and septic shock (secondary cause of death). It was unknown whether an autopsy was performed.


VAERS ID: 422826 (history)  
Form: Version 1.0  
Age: 0.32  
Sex: Male  
Location: Foreign  
Vaccinated:2010-12-16
Onset:2011-03-14
   Days after vaccination:88
Submitted: 2011-05-12
   Days after onset:59
Entered: 2011-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA255AC / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Abnormal faeces, Body temperature increased, Crying, Enema administration, Hypophagia, Intussusception, Restlessness, Rotavirus infection, Rotavirus test positive, Ultrasound abdomen abnormal, Vaccination failure
SMQs:, Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Akathisia (broad), Gastrointestinal obstruction (narrow), Biliary system related investigations, signs and symptoms (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (broad), 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, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature, 14Mar2011, 37.5degC
CDC Split Type: D0071291A

Write-up: This case was reported by a physician, via a public health agency and described the occurrence of ileocoelic intussusception in a 7-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 16 December 2010 and 13 January 2011 the subject received 1st dose and 2nd dose of ROTARIX (oral). On 14 March 2011, 2 months after second vaccination with ROTARIX, the subject experienced ileocolic intussusception. Diagnosis was confirmed by Sonography. Stool test was positive for rotavirus (vaccination failure). The subject was hospitalised for 4 days. At the time of reporting the events were resolved. A hospital report was provided. The subject was hospitalised on 14 March 2011 after crying episodes with bending, decreased food intake and increased body temperature on the day of admission (37.5 degC). Stool was normal and the subject was not vomiting. When admitted, the subject showed no pathologic resistance of the belly. Sonogram of abdomen showed ileocolic intussusception. Hydrostatic disinvagination was performed without complications and the subject received intravenous fluid substitution. On the next day there was an episode of restlessness and crying. Control sonogram showed no new intussusception, control on 16 March 2011 was normal. When admitted, the subject had a badly smelling stool. Stool test confirmed rotavirus infection. There were no signs of gastroenteritis. A reduced effect of vaccination was suspected. On 17 March 2011 the subject was discharged with wellbeing and no further abdominal findings. No further information will be available. This case was also reported to the foreign regulatory authority (PEI).


VAERS ID: 426125 (history)  
Form: Version 1.0  
Age: 0.15  
Sex: Male  
Location: Foreign  
Vaccinated:2011-04-18
Onset:2011-05-10
   Days after vaccination:22
Submitted: 2011-06-24
   Days after onset:45
Entered: 2011-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA150BB / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal mass, Enema administration, Intestinal dilatation, Intestinal operation, Intussusception, Soft tissue mass, Ultrasound abdomen abnormal, X-ray abnormal
SMQs:, Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific dysfunction (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: Abdominal X-ray, 10May2011, see textunits; Ultrasound abdomen, 10May2011, see textunits
CDC Split Type: B0721931A

Write-up: This case was reported by a physician and described the occurrence of intussusception of intestine in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 18 April 2011, the subject received 1st dose of ROTARIX (oral). Between 14-18 days after vaccination with ROTARIX, the subject experienced intussusception of intestine. The physician considered the event was clinically significant (or requiring intervention). The subject was hospitalized and two operations were performed. At the time of reporting, the outcome of the event was unspecified. Subject''s pediatrician had no additional information, they will be provided when available. Follow-up information received on 20 June 2011: The subject had no family history of intussusception or bowel abnormalities, no previous intra-abdominal surgery and no congenital intestinal malformation. A plain abdominal radiograph was performed and showed a visible intussusception or soft tissue mass, fluid levels and dilated bowel loops, and non-specific abnormalities. No demonstration of invagination of the intestine by air or liquid contrast enema and no abdominal CT scan showing a visible intussusceptum or soft tissue, were performed. An abdominal ultrasound was performed and showed a visible intussusception or soft tissue mass and a demonstration of an intra-abdominal mass with specific characteristic features (target sign or doughnut sign on transverse section and a pseudo-kidney or sandwich sign on longitudinal section) that is proven to be reduced by hydrostatic enema on post-reduction ultrasound. The event did not resolve spontaneously and not by a liquid contrast/hydrostatic water/air enema. It required surgical reduction but no resection was performed. The demonstration of invagination at surgery were done on 10 May 2011 and 11 May 2011. The subject did not experience any complications radiological procedure and no complications of surgery. The subject survived at the treatment.


VAERS ID: 428764 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Foreign  
Vaccinated:2011-01-31
Onset:2011-02-04
   Days after vaccination:4
Submitted: 2011-08-04
   Days after onset:180
Entered: 2011-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Biopsy lymph gland abnormal, Cholelithiasis, Decreased appetite, Diarrhoea, Intestinal obstruction, Intussusception, Lymphoid tissue hyperplasia, Rotavirus test negative, Ultrasound abdomen abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Gallbladder related disorders (narrow), Gallstone related disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Malignant lymphomas (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Biopsy of lymph node, see text; Rotavirus test, insignificant; Ultrasound abdomen, see text
CDC Split Type: B0735971A

Write-up: This case was reported by a regulatory authority and described the occurrence of intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline) and (non-gsk) PREVENAR 13. On 31 January 2011, the subject received an unspecified dose of ROTARIX (oral, batch number not provided) and an unspecified dose of PREVENAR 13 (intramuscular, unknown). On 4 February 2011, 4 days after vaccination with PREVENAR 13 and ROTARIX, the subject experienced intussusception, loss of appetite and diarrhea for 4 days. On 7 February 2011, 7 days after vaccination with PREVENAR 13 and ROTARIX, the subject experienced vomiting (about 11 times) with colicky pain. Diarrhea was non-bilious and non-bloody. The subject was hospitalised. Ultrasound of abdomen showed intussusception, and numerous gall bladder calculi. The common duct was not dilated. Intra-op findings showed ileocolic obstruction at right hypochondriac region/hepatic flexure of the transverse colon causing intestinal obstruction. Caecum was high riding at Rho. Stool for rota culture was insignificant. Mesenteric lymph node biopsy showed reactive lymphoid hyperplasia. The subject was treated with ROCEPHINE and FLAGYL. On 11 February 2011, intussusception was resolved. At the time of reporting, the other events were also resolved.


VAERS ID: 428890 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Foreign  
Vaccinated:2011-05-13
Onset:2011-05-31
   Days after vaccination:18
Submitted: 2011-08-05
   Days after onset:66
Entered: 2011-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Crying, Diarrhoea, Emotional distress, Enema administration, Intussusception, Ultrasound abdomen abnormal, X-ray, X-ray abnormal
SMQs:, Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, see text; Ultrasound abdomen, see text
CDC Split Type: B0735969A

Write-up: This case was reported by a regulatory authority and described the occurrence of intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline) and DTPA-IPV-HIB. On 13 May 2011 the subject received an unspecified dose of ROTARIX (oral) and an unspecified dose of DTPA-IPV-HIB (intramuscular unknown). On 31 May 2011, 18 days after vaccination with DTPA-IPV-HIB and ROTARIX, the subject experienced intussusception and non-bloody watery stools. On 4 June 2011, 22 days after vaccination with DTPA-IPV-HIB and ROTARIX, the subject suddenly cried intermittently for 1.5 hours and was inconsolable. The subject was hospitalised. Abdominal x-ray showed paucity of air in the right upper quadrant of the abdomen. Ultrasound of abdomen showed alternating echogenic structure with echolucent centre which was suggestive of ileocolic intussusception in the right flank. The subject was treated with UNASYN and air enema reduction after fluroscopy room showed multiple loops of small and large bowel. On 6 June 2011, the events were resolved.


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