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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: 354066 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-08-13
Entered: 2009-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Gastrointestinal haemorrhage, Intussusception, Surgery, Ultrasound abdomen abnormal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Ultrasound abdomen, see text
CDC Split Type: B0587984A

Write-up: This case was reported by a physician via a sales representative and described the occurrence of intussusception in a child subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of ROTARIX (oral, unknown lot number). At an unspecified time after vaccination with ROTARIX, the subject experienced enterorrhagia. This case was assessed as medically serious by GSK. Abdominal Ultrasound was performed and showed a visible intussusceptum or soft tissue mass. The final diagnosis was intussusception. The subject was treated with a surgical reduction with no resection. At the time of reporting the outcome of the event was unspecified. The physician considered the events were possibly related to vaccination with ROTARIX. This was case 2 of 10 cases of enterorrhagia reported by the same physician. This was all the available information about these children. Despite several attempts, no further information could be obtained. The case has been closed.


VAERS ID: 354067 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-08-13
Entered: 2009-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Gastrointestinal haemorrhage, Intussusception, Surgery, Ultrasound abdomen abnormal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Ultrasound abdomen, see text
CDC Split Type: B0587985A

Write-up: This case was reported by a physician via a sales representative and described the occurrence of intussusception in a child subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of ROTARIX (oral, unknown lot number). At an unspecified time after vaccination with ROTARIX, the subject experienced enterorrhagia. This case was assessed as medically serious by GSK. Abdominal Ultrasound was performed and showed a visible intussusceptum or soft tissue mass. The final diagnosis was intussusception. The subject was treated with a surgical reduction with no resection. At the time of reporting the outcome of the event was unspecified. The physician considered the events were possibly related to vaccination with ROTARIX. This was case 3 of 10 cases of enterorrhagia reported by the same physician. This was all the available information about these children. Despite several attempts, no further information could be obtained. The case has been closed.


VAERS ID: 354068 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-08-13
Entered: 2009-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Gastrointestinal haemorrhage, Intussusception, Surgery, Ultrasound abdomen abnormal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Ultrasound abdomen, see text
CDC Split Type: B0587986A

Write-up: This case was reported by a physician via a sales representative and described the occurrence of intussusception in a child subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of ROTARIX (oral, unknown lot number). At an unspecified time after vaccination with ROTARIX, the subject experienced enterorrhagia. This case was assessed as medically serious by GSK. Abdominal Ultrasound was performed and showed a visible intussusception or soft tissue mass. The final diagnosis was intussusception. The subject was treated with a surgical reduction with no resection. At the time of reporting the outcome of the event was unspecified. The physician considered the events were possibly related to vaccination with ROTARIX. This was case 4 of 10 cases of enterorrhagia reported by the same physician. This was all the available information about these children. Despite several attempts, no further information could be obtained. The case has been closed.


VAERS ID: 356954 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:2009-04-28
Onset:2009-05-04
   Days after vaccination:6
Submitted: 2009-09-10
   Days after onset:129
Entered: 2009-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN

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: B0578020A

Write-up: This case was reported by a physician via a sales representative and described the occurrence of intussusception in a 10-week-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 28 April 2009, the subject received 1st dose of ROTARIX (unknown route, lot number not provided). On 4 May 2009, 6 days after vaccination with ROTARIX, the subject experienced intestinal intussusception. The subject was hospitalised and the physician considered the event was clinically significant (or requiring intervention). At the time of reporting the event was worse. The physician considered the event was possibly related to vaccination with ROTARIX. Additional information has been requested. Follow up information received on 2 September 2009: The physician reported that the subject had fully recovered after a surgical procedure. The events were resolved. No further information has been received, the case has been closed.


VAERS ID: 357655 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:2009-08-26
Onset:2009-09-05
   Days after vaccination:10
Submitted: 2009-09-18
   Days after onset:13
Entered: 2009-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Diarrhoea, Echography abnormal, Haematochezia, Intussusception, Malaise, Surgery, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow)

Life Threatening? Yes
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: Echography, IS
CDC Split Type: B0593093A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 26 August 2009 the subject received 1st dose of ROTARIX (oral). On 5 September 2009, 10 days after vaccination with ROTARIX, the subject experienced diarrhea and malaise which lasted till 06 September 2009. On 07 September 2009 she had vomiting, bloody stools and intussusception. The subject was hospitalised and the physician considered the events were life threatening. Relevant test results done on 07 September 2009 included echography which showed intussusception. Therefore the subject underwent a surgery. On 9 September 2009, the events were resolved. The physician considered that diarrhea, malaise, vomiting and bloody stools were possibly related to vaccination with ROTARIX.


VAERS ID: 358424 (history)  
Form: Version 1.0  
Age: 0.22  
Gender: Male  
Location: Foreign  
Vaccinated:2009-08-20
Onset:2009-08-23
   Days after vaccination:3
Submitted: 2009-09-25
   Days after onset:33
Entered: 2009-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CA571A / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 067875 / 1 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA866A / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abnormal faeces, Acid base balance normal, Basophil percentage decreased, Blood chloride normal, Blood creatinine normal, Blood potassium increased, Blood sodium normal, Blood urea normal, Body temperature increased, C-reactive protein increased, Crying, Diarrhoea, Differential white blood cell count abnormal, Eating disorder, Eosinophil percentage, Fatigue, Haematocrit decreased, Haemoglobin normal, Heart rate increased, Intussusception, Lymphocyte percentage, Mean cell haemoglobin normal, Mean cell volume normal, Monocyte percentage increased, Neutrophil percentage decreased, Platelet count increased, Protein total normal, Red blood cell count normal, Seborrhoeic dermatitis, Skin turgor decreased, Stool analysis normal, Tongue discolouration, Ultrasound scan abnormal, Vomiting, White blood cell count normal
SMQs:, Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Biliary system related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Chronic kidney disease (broad), Myelodysplastic syndrome (broad), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? Yes
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: Gestational Diabetes
Allergies:
Diagnostic Lab Data: Acid-base balance, 23Aug2009, normal; Basophil percentage, 23Aug2009, 0%; Blood chloride, 23Aug2009, normal; Blood creatinine, 23Aug2009, normal; Blood potassium, 23Aug2009, 5.7mmol/l; Blood sodium, 23Aug2009, normal; Blood urea, 23Aug2009, normal; Body temperature, 23Aug2009, 37.2degC; C-reactive protein, 23Aug2009, 0.46mg/dl; Eosinophil percentage, 23Aug2009, 1%; Heart rate, 23Aug2009, 108/min; Hematocrit, 23Aug2009, 34.7%; Hemoglobin, 23Aug2009, 11.6g/dl; Lymphocyte percentage, 23Aug2009, 31%; MCH, 23Aug2009, 28.0pg; MCHC, 23Aug2009, 33.5g/dl; MCV, 23Aug2009, 83.7fl; Monocyte percentage, 23Aug2009, 11%; Neutrophil percentage, 23Aug2009, 51%; Platelet count, 23Aug2009, 76910e9/l; Protein total, 23Aug2009, normal; Red blood cell count, 23Aug2009, 4.110e12/l; White blood cell count, 23Aug2009, 8.710e9/l; Differential blood count, performed on 23 August 2009: Large unstained cells (LUC): 5 %. Stool examination: Negative for Rotavirus, Adenovirus and Norovirus antigens. Sonography, performed on 24 August 2009: Urinary bladder filled with fluid, no free fluid retrovesical, some free fluid in Morison''s pouch. Intestinal loops delicate, filled with stool and fluid, non-propulsive peristalsis. Characteristic cocarde structure (target-ring form) for invagination from right upper abdomen to the lower abdomen. Post hydrostatic disinvagination fluid flow into small bowels restored. Bauhin''s ileocecal valve appeared thickened.
CDC Split Type: D0062717A

Write-up: This case was reported by a hospital physician and described the occurrence of invagination of intestine in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). According to follow-up information received from the foreign regulatory authority the subject was vaccinated with ROTARIX (GlaxoSmithKline), INFANRIX HEXA (GlaxoSmithKline) and PREVENAR (Wyeth) (non-GSK). On an unknown date in 2009 the subject received the first dose of ROTARIX (0.5 ml, oral). Approximately 3 - 4 days post vaccination with ROTARIX, on an unknown date in 2009, the subject experienced invagination of intestine. The subject was hospitalised for an unknown period of time. Up to now surgery has not been necessary. Defecation was possible again. At the time of reporting, on 25 August 2009, the event was unresolved. Follow-up information from the reporting physician has been requested. Follow-up information including a hospital report was received from a foreign regulatory authority (DE-PEI-PEI2009020419). According to follow-up information received from the foreign regulatory authority the subject was vaccinated with ROTARIX (GlaxoSmithKline), INFANRIX HEXA (GlaxoSmithKline) and PREVENAR (Wyeth) (non-GSK). On 20 August 2009 the subject received the first dose of ROTARIX (0.5 ml, oral), the first dose of INFANRIX HEXA (0.5 ml, intramuscular, right thigh) and the first dose of PREVENAR (0.5 ml, intramuscular, left thigh). Approximately three days post vaccination with ROTARIX, INFANRIX HEXA and PREVENAR, on 23 August 2009, the subject experienced invagination of intestine. The subject was hospitalised on 23 August 2009 for five days. The reporter considered that the event was life threatening. The event was confirmed by sonography. Treatment included hydrostatic disinvagination, performed on 24 August 2009. The subject was discharged from hospital on 27 August 2009. At the time of reporting, on 07 September 2009, the events were resolved. According to anamnesis of the hospital report the subject experienced recurrent vomiting, inability to eat, and multiple episodes of watery stools, associated at first with crying abnormal, on 23 August 2009. Family anamnesis included gestational diabetes of mother. The subject''s birth was without complications. On admission to hospital the subject was tired, crying post severe stimulation, but otherwise rather calm. Skin turgor was reduced, the tongue was coated, fontanel was soft and at level. The head was asymmetric with flattened back of the head and milk crust (seborrheic dermatitis). Abdomen was soft with lively peristalsis of all four quadrants, without signs of guarding or pathologic resistances. Examinations of heart, skeleton and genitals, as well as neurological examinations, were normal. Body temperature was normal (37.2 degC). At first the subject was treated with dextrose + electrolytes (Glucose + electrolytes) solution. General condition did not improve. The subject still experienced vomiting, was unable to keep food and was unable to have stools. Abdominal sonography showed characteristic target signs for invagination. Treatment included hydrostatic disinvagination which has been successful. Oral nutrition build-up was well tolerated. Control sonography showed intestinal loops in the lower abdomen with thickened wall, but otherwise normal peristalsis without signs of re-invagination. On 27 August 2009 the subject was discharged from hospital. The events were resolved. The subject was eating (drinking) normally and showed regular stools. The hospital physician(s) considered that a causal relationship of the evens to vaccination with ROTARIX, received three days prior to start of the events, cannot be excluded completely. Follow-up information from the reporting physician was still pending.


VAERS ID: 358940 (history)  
Form: Version 1.0  
Age: 0.22  
Gender: Male  
Location: Foreign  
Vaccinated:2009-08-20
Onset:2009-08-23
   Days after vaccination:3
Submitted: 2009-09-29
   Days after onset:37
Entered: 2009-09-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CA571A / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D67875 / 1 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA866A / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood potassium increased, Blood potassium normal, C-reactive protein normal, Diarrhoea, Differential white blood cell count abnormal, Haematocrit decreased, Haemoglobin normal, Hypophagia, Intussusception, Lymphocyte percentage, Monocyte percentage increased, Neutrophil percentage decreased, Platelet count increased, Ultrasound abdomen abnormal, Virus stool test negative, Vomiting
SMQs:, Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (broad), Haemorrhage laboratory terms (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (broad), Myelodysplastic syndrome (broad), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (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? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Allergies:
Diagnostic Lab Data: On 23-Aug-2009 test results were: haematocrit (results: 34.7 %); virus stool test (results: rotavirus, adenovirus, norovirus negative); blood potassium (results: 5.7 mmol/L); c-reactive protein (results: 0.46 mg/dL); haemoglobin (results: 11.6 g/dL); differential white blood cell count abnormal (results: 5%); platelet count (results: 769x10^9/L; neutrophil count (results: 51 %); lymphocyte count (results: 31 %); and monocyte count (results: 11 %). Ultrasound scan (results: abdomen: stool- and liquid-filled intestine with non-propulsive peristalsis, double cockade in terms of an invagination from the right upper abdomen to the lower abdomen) was done on 24-Aug-2009.
CDC Split Type: DEWYEG04504609

Write-up: Information regarding PREVENAR was received from a healthcare professional via a regulatory authority regarding a 2-month-old male patient who experienced invagination of intestine, vomiting and watery stools. Food intake was not possible. The patient received the first dose on 20-Aug-2009. Additional suspect medication included INFANRIX HEXA. On 23-Aug-2009 the patient experienced recurrent vomiting, many watery stools. Food intake was not possible. The patient was hospitalized from 23-Aug-2009 to 27-Aug-2009. An ultrasound scan of abdomen on 24-Aug-2009 showed a stool- and liquid-filled intestine with non-propulsive peristalsis and a double cockade in terms of an invagination from the right upper abdomen to the lower abdomen. Treatment included hydrostatic desinvagination with 500 ml Ringer solution. As a result liquid transfer to the small intestine detectable and the ileocecal valve appears thickened. The patient recovered and was discharged on 27-Aug-2009. The reporter can not exclude a causal relationship to the vaccination with ROTARIX. This case is being treated according to the country''s act.


VAERS ID: 377268 (history)  
Form: Version 1.0  
Age: 0.33  
Gender: Male  
Location: Foreign  
Vaccinated:2009-10-15
Onset:2010-01-07
   Days after vaccination:84
Submitted: 2010-01-18
   Days after onset:11
Entered: 2010-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA896A / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Intussusception, Rotavirus test positive
SMQs:, Gastrointestinal obstruction (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Rotavirus test, 07Jan2010, positive
CDC Split Type: B0624230A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 6-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 15 October 2009 and 14 August 2009 the subject received 2nd dose and 1st dose of ROTARIX (oral). On 7 January 2010, 84 days after vaccination with the 2nd dose of ROTARIX, the subject experienced intussusception, rotavirus test positive. The subject came back recently from travel. The subject was hospitalised. At the time of reporting the events were unresolved.


VAERS ID: 379303 (history)  
Form: Version 1.0  
Age: 0.39  
Gender: Male  
Location: Foreign  
Vaccinated:2009-12-07
Onset:2009-12-25
   Days after vaccination:18
Submitted: 2010-02-03
   Days after onset:40
Entered: 2010-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Body temperature normal, Crying, Dehydration, Diarrhoea, Enterocutaneous fistula, Haematochezia, Intensive care, Intestinal obstruction, Intussusception, Sepsis, Surgery, Vomiting
SMQs:, Acute pancreatitis (broad), Agranulocytosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal perforation (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (narrow), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
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: Body temperature, 20Jan2010, 36.6deg C
CDC Split Type: B0630285A

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 bacillus CALMETTE-GUERIN vaccine (non-gsk); non-GSK manufacturer; unknown given on 1 September 2009; DTP (A or W no known) vaccine; manufacturer unspecified given on 1 September 2009; ROTARIX vaccine; manufacturer unspecified; unknown given on 2 October 2009; poliomyelitis vaccine, unspecified; manufacturer unspecified given on August 2009, 19 September 2009 and 7 December 2009. On 7 December 2009 the subject received 2nd dose of ROTARIX vaccine (unknown). On 25 December 2009, 18 days after vaccination with ROTARIX, the subject cried. On 26 December 2009 he had blood in stools, fetid vomiting, tense abdomen and abdominal pain. The subject was hospitalized and transferred to intensive care unit and he underwent a surgery due to intestinal obstruction. He was hospitalized since 03 January 2010 with hypothetic diagnosis of late post-operative obstructive acute abdomen (including intussusception, enterocutaneous fistula, sepsis, diarrhea and dehydration. On 20 January 2010 the subject was hospitalized in the paediatric ICU (weight 10.22 Kg. body temperature 36.6 deg C, active and reactive, hydrated, breathing spontaneously, he was receiving parenteral nutrition the abdomen was flaccid and painful with enterocutaneous fistula on the left side with sero-purulent secretion, maintained open nasogastric probe with high bilious debit. On 27 January 2010 the subject''s conditions was critical and he require a second surgery. At the time of reporting the outcome of the events was unspecified.


VAERS ID: 379900 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2010-01-01
Onset:2010-01-29
   Days after vaccination:28
Submitted: 2010-02-09
   Days after onset:11
Entered: 2010-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Haematochezia, Intussusception, Irritability, Surgery
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Hypoglycaemia (broad)

Life Threatening? 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: B0630353A

Write-up: This case was reported by a sales representative and described the occurrence of intussusception in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Physician or other health care professional has not verified this report. On 1 January 2010 the subject received 1st dose of ROTARIX (oral). On 29 January 2010, 28 days after vaccination with ROTARIX, the subject experienced irritability, colicky abdominal pain and blood in stools. The physician diagnosed intussusception, therefore the same day the subject underwent a surgery. The subject was hospitalised and the sales representative reported that the events were life threatening and clinically significant (or requiring intervention). At the time of reporting the events were improved. The sales representative reported that the events were possibly related to vaccination with ROTARIX.


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