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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: 384490 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-04-07
Entered: 2010-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Crying, Diet refusal, Enema administration, Intussusception, Ultrasound scan abnormal, X-ray abnormal
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Depression (excl suicide and self injury) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Ultrasound scan, intussusception; X-ray, intussusception
CDC Split Type: B0645429A

Write-up: This case was reported by a foreign regulatory authority (AM20090420) and described the occurrence of intussusception of intestine in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Medical conditions and concurrent medications were unspecified. The subject weighted 5.8 kg and measured 57 cm. On an unspecified date, the subject received a 1st dose of ROTARIX (batch unknown, oral). Three days after vaccination with ROTARIX, the subject was hospitalized for crying and refusal to eat. Ultrasound scan and X-ray showed intussusception of intestine, reduced by hydrosoluble enema. All the events resolved. According to the foreign method of assessment, the relationship between vaccination with ROTARIX and the reported events was dubious.


VAERS ID: 384491 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Foreign  
Vaccinated:2006-12-08
Onset:2007-04-14
   Days after vaccination:127
Submitted: 2010-04-07
   Days after onset:1089
Entered: 2010-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41DA194B / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Enema administration, Intussusception, Laboratory test abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: At the time of ROTARIX administration, no other vaccine was administered, no concurrent medication was taken, no vomiting or diarrhea episode occurred.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0645472A

Write-up: This case was reported by the regulatory authority (reference RN0700227) and described the occurrence of intussusception of intestine in a 6.5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). At the time of ROTARIX administration, no other vaccine was co-administered, no concurrent medication was taken. At the time of events, the subject weighted 8 kg and measured 71 cm. On 08 December 2006, the subject received a 1st dose of ROTARIX (batch A41DA194B, oral). There was no vomiting or diarrhea episode at the time of vaccination. On 14 April 2007, four months after vaccination with ROTARIX, the subject was hospitalized for abdominal pain and vomiting without rectorrhagia due to an acute ileocolic intussusception (unspecified diagnostic test). Intussusception was reduced by air enema under general anaesthesia. Bowel movements passed normally on day two. The regulatory authority reported that the events were life threatening. According to the method of assessment, the relationship between vaccination with ROTARIX and the reported event was dubious.


VAERS ID: 384492 (history)  
Form: Version 1.0  
Age: 0.28  
Sex: Female  
Location: Foreign  
Vaccinated:2007-12-11
Onset:2008-01-09
   Days after vaccination:29
Submitted: 2010-04-07
   Days after onset:818
Entered: 2010-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 AR / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 AR / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 AR / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 2 UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA392A / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Body temperature normal, Condition aggravated, Diarrhoea, Diarrhoea haemorrhagic, Enema administration, Fatigue, Intussusception, Irritability, Pain, Pyrexia, Ultrasound abdomen abnormal, Vomiting, Weight decreased
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (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), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Racecadotril; Ibuprofen;Paracetamol; Hydration therapy
Current Illness: Bloody diarrhea; fever; mucous diarrhea; reflux unspecified; vomiting; weight loss
Preexisting Conditions: Subject born at 40 weeks and 4 days of amenorrhea, birth weight 3.27 kg, birth height 49.5 cm, birth cranial perimeter 34.5 cm. No known allergies. At the time of event, there were gastroenteritis cases in the family.
Allergies:
Diagnostic Lab Data: Blood pressure, 09Jan2008, 107/77; Body temperature, 09Jan2008, normal; Heart rate, 09Jan2008, 156bpm; Ultrasound abdomen, 09Jan2008, see text; 09 January 2008, Abdominal ultrasound scan: suspicion of intussusception of intestine
CDC Split Type: B0645474A

Write-up: This case was reported by a foreign regulatory authority (reference PV20080062) and described the occurrence of intussusception of intestine in a 4-month-old female subject who was vaccinated with ROTARIX, GlaxoSmithKline, PREVENAR, non-gsk and PENTAVAC, non-gsk. The subject was born at 40 weeks and 4 days of amenorrhea (birth weight 3.27 kg, birth height 49.5 cm and birth cranial perimeter 34.5 cm). She had no known allergy. Medical condition included unspecified reflux. At the time of the events, there were gastroenteritis cases in the subject''s family. The subject weighted 7.18 kg. On 11 December 2007, the subject received an unspecified dose of ROTARIX (batch A41CA392A oral), a 2nd dose of PREVENAR (intramuscular, batch and injection site unknown), and a 2nd dose of PENTAVAC (intramuscular, batch and injection site unknown). On 08 January 2008, a physician was consulted for acute diarrhea with several vomiting and fever at 38.7 degrees Celsius. Diarrhea had become a mucous bloody diarrhea (10 liquid stools per day; with a weight loss of four percent (incidental events). TIORFAN, ADVIL, DOLIPRANE and oral rehydration solution were prescribed. Vomiting and diarrhea persisted. On 09 January 2008, 29 days after vaccination with PENTAVAC, PREVENAR and ROTARIX, the subject was admitted to emergency service for bloody diarrhea and pain. On admission, blood pressure was at 107/77, heart rate at 156 bpm and body temperature was normal. The subject was irritable and tired. There was no sign of dehydration. The rest of physical examination was normal. At abdominal ultrasound scan, acute intussusception of intestine was suspected. The subject was hospitalized and intussusception was reduced by hydrosoluble enema. Intussusception of intestine resolved at an unspecified date. Outcome of pain, blood in stool, irritability and fatigue was unspecified. According the foreign method of assessment, the relationship between vaccinations with ROTARIX, PREVENAR and PENTAVAC and intussusception was dubious.


VAERS ID: 384493 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2007-04-16
Onset:2007-04-21
   Days after vaccination:5
Submitted: 2010-04-07
   Days after onset:1082
Entered: 2010-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Haematochezia, Intussusception, Mucous stools, No reaction on previous exposure to drug, Surgery, Ultrasound scan abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Malignancy related therapeutic and diagnostic procedures (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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Ultrasound scan, Apr2007, intussusception
CDC Split Type: B0645476A

Write-up: This case was reported by the regulatory authority (reference NY20070053) and described the occurrence of intussusception of intestine in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Medical conditions and concurrent medications were unspecified. Previous vaccination included a first dose of ROTARIX given on 13 March 2007, well tolerated. On 16 April 2007, the subject received a 2nd dose of ROTARIX (batch unknown, oral). On 21 April 2007, five days after vaccination with ROTARIX, the subject was hospitalized for vomiting, bloody and mucous stools without abdominal pain. As vomiting were persisting, an abdominal ultrasound scan was performed and revealed acute intussusception of intestine. Clinical course was favorable after surgery. On 23 April 2007, after three days of hospitalisation, the subject was discharged from hospital. At the time of reporting, intussusception of intestine was improved and other events were resolved. According to the method of assessment, the relationship between vaccination with ROTARIX and the reported events was dubious.


VAERS ID: 384838 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2008-02-12
Onset:2008-02-17
   Days after vaccination:5
Submitted: 2010-04-09
   Days after onset:781
Entered: 2010-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS A20CA391B / UNK GM / SC
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA526A / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Apathy, Barium double contrast, Bowel movement irregularity, Diet refusal, Echography abnormal, Flatulence, Intussusception, Subileus, Vomiting
SMQs:, Acute pancreatitis (broad), Dementia (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (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: Pyrimethamine; Sulphadiazine; Calcium folinate
Current Illness: Unknown
Preexisting Conditions: Congenital Toxoplasmosis; The subject had no past medical history of intestinal invagination, abdominal surgery and intestinal malformation. No family history of intestinal invagination. There was a family functional colopathy.
Allergies:
Diagnostic Lab Data: Echography, 17Feb2008, Abnormal; 17 February 2008: The echography revealed an ileocaecal intestinal invagination with mesenteric ganglions. Reduction of invagination by gastrografin enema, controlled on post reduction echography.
CDC Split Type: B0509703A

Write-up: This case was reported by a physician, via a GSK sales representative and described the occurrence of invagination of intestine in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent medical condition included treated congenital toxoplasmosis (NOS). The subject had no past medical condition of intestinal malformation and intestinal invagination. There was a family functional colopathy. In February 2008, the subject received a 1st dose of ROTARIX (batch number not available). On 17 February 2008, 14 days after vaccination with ROTARIX, the subject was hospitalized. At the echography, a diagnosis of ileocaecal invagination of intestine with mesenteric ganglions was made. The subject was treated with enema and the subject recovered. The hospital physicians evoked a possible relation between toxoplasmosis and mesenteric ganglions. The physician considered the events were unrelated to vaccination with ROTARIX (temporal association but non causal). Follow up received on 12 March 2008: The subject had no past medical history of intestinal invagination, abdominal surgery and intestinal malformation. There was no family history of intestinal invagination. Medical condition included congenital toxoplasmosis (maternal antibodies became positive during the pregnancy), treated with ADIAZINE and pyrimethamine since birth. On 12 February 2008, the subject received a first dose of ROTARIX (batch number A41CA526A) and a dose of INFANRIX QUINTA (batch number A20CA391B, right gluteal, subcutaneous). Five days later, on 17 February 2008, the subject developed moderate occlusive syndrome (intestinal obstruction) with vomiting and cessation of feces and flatus. Diagnosis of acute intestinal (ileocaecum) invagination was made on echography. No abdominal scan and X-ray was performed. The intestinal invagination was reduced by gastrografin enema, controlled on post reduction echography. ROTARIX has not been readministered. The reporter considered that the events were possibly related to vaccination with ROTARIX. Upon follow-up received from the agency (PB20080160) on 02 April 2010: Concurrent medication included ADIAZINE (500 mg/kg/day), MALOCIDE (2/5 mg/kg/day) and FOLINORAL (50 mg/kg/day) since birth. These drugs have not been stopped following the events. On 17 February 2008, the subject was admitted at hospital due to apathy and refusal to eat during more than 12 hours. Clinical course was favorable after enema. The subject recovered without sequelae in 48 hours. According to the foreign method of assessment, the causal relationship, between the reported events and vaccination with ROTARIX was dubious. This case has been closed; no more information will be available.


VAERS ID: 385011 (history)  
Form: Version 1.0  
Age: 0.35  
Sex: Male  
Location: Foreign  
Vaccinated:2006-09-07
Onset:2006-09-10
   Days after vaccination:3
Submitted: 2010-04-13
   Days after onset:1311
Entered: 2010-04-13
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 pain upper, Barium double contrast, Blood urine present, Echography abnormal, Enema administration, Full blood count normal, Haematochezia, Inappropriate schedule of drug administration, Intussusception, Irritability, Malaise, Urine analysis normal, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage 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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), 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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cough; Rhinitis
Preexisting Conditions: The subject was not a premature baby. He had no past medical condition of digestive malformation. The subject and his family had no past medical history of intussusception. One week before this vaccination with ROTARIX, the subject presented with cough and rhinitis.
Allergies:
Diagnostic Lab Data: Echography, 11Sep2006, Abnormal; Full blood count, 10Sep2006, Normal; Thorax X-ray, 10Sep2006, Normal; X-ray, 11Sep2006, Abnormal; On 10 September 2006: urinary analysis: normal (without blood); On 11 September 2006: Abdominal echography and X-ray with therapeutic enema confirmed intussusception at right colon level.
CDC Split Type: B0438481A

Write-up: This case was reported by two physicians, including one via a GSK sales representative and described the occurrence of invagination of intestine in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was not a premature baby. He had no relevant past medical condition of digestive malformation. One week before the vaccination with ROTARIX, the subject presented with cough and rhinitis. On 08 September 2006, the subject received a 1st dose of ROTARIX (batch number not available, oral). On 10 September 2006, two days after vaccination, the subject did not feel good and according to his parents he developed blood in urine. At the emergency unit, urinary analysis was negative and full blood cell count and thorax X-ray were normal. In the night between 10 and 11 September 2006, he vomited twice. On 11 September 2006, in the morning, the subject did not feel good and was grumpy. According to his parents, he presented with blood in stools. Clinical examination showed pain on palpation at right hypochondrium level. He was thus hospitalized. Echography and X-ray with therapeutic enema were performed and confirmed the diagnosis of invagination of intestine. Quickly, the subject was discharged from hospital and the events were resolved. At the time of reporting, the subject was in good health condition. The reporters'' causality assessment was unknown. Follow up received on 11 October 2006 from the hospital physician: The subject and his family had no past medical history of intussusception. At the hospital, clinical symptomatology evoked acute invagination of intestine. Abdominal echography and X-ray with therapeutic enema confirmed invagination of right colon. The events resolved on 11 September 2006 after the therapeutic enema. The reporter (hospital physician) considered that the invagination of intestine was possibly related to the vaccination with ROTARIX. Vaccination course has been discontinued. Follow-up information was received on 27 November 2006 by the agency (LL0600318) and reported that according to the foreign method of imputability, the events were dubiously related to ROTARIX vaccine. Follow up of 23 November 2007: This case has been closed; no more information will be available. Follow-up of 02 April 2010 by the agency: Correction of ROTARIX vaccination date: 07 September 2006 instead of 08 September 2006. Time to onset of intussusception was thus 3 days instead of two days. No new information was received.


VAERS ID: 385407 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Unknown  
Location: Foreign  
Vaccinated:2009-10-01
Onset:2009-10-05
   Days after vaccination:4
Submitted: 2010-04-19
   Days after onset:196
Entered: 2010-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death, Intussusception, Similar reaction on previous exposure to drug, Surgery
SMQs:, Gastrointestinal obstruction (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-05
   Days after onset: 0
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: INVAGINATION OF INTESTINE
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0647700B

Write-up: This case was reported by a physician and described the occurrence of invagination of intestine in a 4-month-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). Previous vaccination included 1st dose of ROTARIX (GlaxoSmithKline; oral) given on 29 July 2009. After vaccination with 1st dose of ROTARIX, the subject experienced first episode of intestinal invagination (See case B0647700A). On 1 October 2009, the subject received 2nd dose of ROTARIX (oral). On 5 October 2009, 4 days after vaccination with 2nd dose of ROTARIX, the subject experienced a second episode of intestinal invagination. The subject was hospitalised. Surgery was performed and the subject died on the same day at 9:45 PM. The subject died from intestinal invagination caused by vaccination. It was unknown whether an autopsy was performed. The physician considered the event was almost certainly related to vaccination with ROTARIX.


VAERS ID: 386353 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-04-30
Entered: 2010-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Intussusception
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? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0642159A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 4-month-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of ROTARIX (oral). At an unspecified time after vaccination with ROTARIX, the subject experienced intussusception. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. Follow-up information received on 30 April 2010: Further information have been asked but could not be obtained, this case was therefore closed.


VAERS ID: 386885 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2007-10-03
Onset:2007-10-09
   Days after vaccination:6
Submitted: 2010-05-06
   Days after onset:940
Entered: 2010-05-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Diarrhoea, Diet refusal, Echography abnormal, Enema administration, Gastrointestinal oedema, Haematochezia, Intestinal anastomosis, Intestinal resection, Intussusception, Laparotomy, Lymphadenopathy, Surgery, Vomiting
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
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: Echography, 11Oct2007, Invagination
CDC Split Type: B0497642A

Write-up: This case was reported by a physician and described the occurrence of invagination of intestine in a 4-month-old male subject who was vaccinated with ROTARIX, (GlaxoSmithKline). On an unspecified date the subject received the 1st dose of ROTARIX (unknown). Approximately 8 days after vaccination with the 1st dose of ROTARIX, the subject experienced invagination of intestine. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. Follow up information received on 29 November 2007 (the physician has been contacted by phone): The subject was hospitalised. The patient was operated: partial intestinal resection. Further information has been requested. Follow up information received on 08 February 2008: The subject had no family history of intussusception or bowel abnormalities. The subject had no previous intra-abdominal surgery. The subject had no history of intussusception or congenital intestinal malformation. On 3 October 2007, the subject received the 1st dose of ROTARIX (oral). On 9 October 2007, 6 days after vaccination with the 1st dose of ROTARIX, the subject refused to eat. He experienced vomiting with jet in 2 to 3 occasions. He had liquid stools with trace of blood in stools. On 11 October 2007, physical exam reported palpation of induration at the level of right hypochondrium. Abdominal echography was performed and showed the following: Evidence of small lamina of light fluid effusion, at the level of parieto-colic splint and Douglas. Absence of abnormality in the liver, spleen and 2 kidneys. Clear presence of a tube of invagination in a median transverse position with thickening of receptor colon at 8 mm of diameter. The wall was very hypo-echogenic showing intestinal edema. It was contained intestinal loop with its mesentery containing enlargement of lymph nodes in favour of ileo-cecal invagination. The mesentery was widely vasculared. Important stasis of small intestine upstream. Ileo-cecal invagination with the head located in medio-transverse with important right colic parietal edema. Enema with gastrophine was performed in order to reduce the ileo-cecal invagination and showed hyperaeration of small intestine with small distention without any argument in favour of pneumopertoneum. Rapid casting of the head of tube of invagination which was located after the right colic angle. Rapidly this angle was made opaque but despite 3 attempts, no more important reduction was obtained. On morphological level; it was noticed an abnormal mucography of 2/3 of proximal colon transverse in relation more probably with parietal edema. On 11 October 2007, laparotomy with ileo-cecal resection with ileo-colic anastomosis was done; Cecal perforation was discovered. The subject was hospitalised and the physician considered the events were disabling, life threatening and clinically significant (or requiring intervention). At the time of reporting the events were resolved with following sequelae: ileo-cecal resection with ileo-colic anastomosis. The physician considered the events were possibly related to vaccination with ROTARIX. Follow up information received on 02 April 2010: This case was also reported by a regulatory authority (#NY20070349).


VAERS ID: 386984 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2010-01-15
Onset:2010-02-02
   Days after vaccination:18
Submitted: 2010-05-07
   Days after onset:93
Entered: 2010-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Body temperature increased, Enema administration, Intussusception, Pyrexia, Ultrasound scan abnormal
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: No relevant medical history
Allergies:
Diagnostic Lab Data: Body temperature, 02Feb2010, increased; Ultrasound scan, Feb2010, intussusception
CDC Split Type: B0650695A

Write-up: This case was reported by the regulatory authority (BX20100405) and described the occurrence of intussusception of intestine in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant past medical history. On 15 January 2010, the subject received an unspecified dose of ROTARIX (batch unknown, oral). On 02 February 2010, 18 days after vaccination with ROTARIX, the subject presented with febricula and abdominal pain leading to hospitalisation. Ultrasound scan confirmed diagnosis of acute intussusception of intestine. Intussusception was reduced by enema. On 05 February 2010, febricula and abdominal pain resolved. From 18 to 19 March 2010, the subject was again hospitalized for a new episode of abdominal pain probably unrelated to previous intussusception. A virosis was evoked (incidental events). ROTARIX has not been readministered. According to the method of assessment, the relationship between the reported events and vaccination with ROTARIX was dubious.


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