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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: 451174 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2009-03-30
Onset:2009-04-20
   Days after vaccination:21
Submitted: 2012-03-06
   Days after onset:1051
Entered: 2012-03-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Crying, Enema administration, Intussusception, Rectal haemorrhage, Ultrasound scan abnormal, Vomiting, X-ray abnormal
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), 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? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Gastroenteritis
Preexisting Conditions: Born at 40 weeks of amenorrhea (birth weight 3.35 kg); Exclusively breast feeding; No relevant medical history
Allergies:
Diagnostic Lab Data: Ultrasound scan, 30Apr2009, suggestive; Ultrasound scan, 30Apr2009, intussusception
CDC Split Type: B0784552A

Write-up: This case was reported by a CRO during during a prospective study and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject weighed 6.935 kg and measured 60 cm. She was born at 40 weeks of amenorrhea (birth weight 3.35 kg). The subject was exclusively breast fed and had no relevant medical history. Within the 15 days before the events, the subject had a gastroenteritis resolved at the time of hospitalization but did not received any treatment. Concurrent vaccinations included a first dose of INFANRIX HEXA and a first dose of PREVENAR given on 06 February 2009 and a second dose of INFANRIXQUINTA given on 30 March 2009. On 30 March 2009, the subject received a first dose of ROTARIX (batch and route unknown) and her second dose of INFANRIXQUINTA. First symptoms occurred on 28 April 2009, about 29 days after administration of the first dose of ROTARIX. On 30 April 2009, the subject was admitted to emergency unit then hospitalized in an other hospital. Report from emergency unit was not available. On admission, the subject presented with abnormal crying, vomiting (milk) and rectorrhagia. After hospitalization, no physical examination was made. Abdominal X-ray and abdomino pelvic ultrasound scan results were suggestive of intussusception with hydroaeric level. Intussusception was reduced with water enema. Clinical course was favourable, the subject was discharged from hospital on 01 May 2009. Brighton score was quoted at 1 by a scientific committee. At the time of reporting, the events were resolved. The reporter''s assessment were not provided.


VAERS ID: 451175 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2008-10-03
Onset:2008-10-21
   Days after vaccination:18
Submitted: 2012-03-06
   Days after onset:1232
Entered: 2012-03-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME) / SANOFI PASTEUR A20CA444A / 2 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 34254 / 1 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA665A / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal mass, Apathy, Constipation, Crying, Diet refusal, Enema administration, Intussusception, Pallor, Rectal haemorrhage, Shock, Small intestinal resection, Ultrasound abdomen abnormal, Vitello-intestinal duct remnant, Vomiting, X-ray abnormal, X-ray with contrast
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Dementia (broad), Congenital, familial and genetic disorders (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (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, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Paracetamol; PRORHINEL
Current Illness: Rhinitis
Preexisting Conditions: Born at 37 weeks of amenorrhea, birth weight 2.99 kg. Mixed feeding without diversified diet. No relevant medical history.
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 22Oct2008, intussusception; Abdominal X-ray, 22Oct2008, with contrast ag; Ultrasound scan, 22Oct2008, suggestive of in
CDC Split Type: B0784281A

Write-up: This case was reported by a CRO during a prospective study (EPIstudy) and described the occurrence of intussusception in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject weighed 6.12 kg and measured 59 cm. He was born at 37 weeks of amenorrhea (birth weight 2.99 kg). He had mixed feeding without diversified diet. Within the 15 days before the event, the subject had a rhinitis. He had no other relevant medical history. Concurrent vaccinations included a first dose of INFANRIX HEXA (batch A21CA409A), a first dose of ROTARIX (batch A41CA620) and a first dose of PREVENAR (batch 34254) given on 02 September 2008 and a second dose of INFANRIX QUINTA (batch A20CA444A) and a second dose of PREVENAR (batch 34254) given on 03 October 2008. Within the 15 days before the event, the subject was treated with DOLIPRANE and PRORHINEL. On 03 October 2008, the subject received a second dose of ROTARIX (batch A41CA665A, route unknown), a second dose of INFANRIX QUINTA and a second dose of PREVENAR. First symptoms occurred on 21 October 2008, 18 days after administration of ROTARIX. On 22 October 2008, the subject was admitted to emergency unit with abnormal crying, pallor, apathy, refusal to eat, vomiting (food and bile) and no bowel movements. Abdominal X-ray with or without contrast agent and abdomino pelvic ultrasound scan results were suggestive of intussusception with hydroaeric level. Brighton score was at 1. The subject was hospitalized in pediatric surgery unit where he was in a state of shock. Two treatments by barium enema were ineffective. On 23 October 2008, the subject was transferred in an other hospital. On admission, physical examination evidenced abdominal distension with a palpable sausage-shaped mass and presence of blood at rectal examination. A new barium enema was ineffective. A partial resection of small intestine (6 cm) was performed and localized the intussusception in ileoileal transvalvular part of the small intestine related to the presence of Meckel''s diverticulum. Anatomopathological examination was performed and confirmed the diagnosis of intussusception of small intestine with Meckel''s diverticulum. Clinical course was favourable and the subject was discharged from hospital on 29 October 2008. Brighton score was quoted at 1 by a scientific committee. At the time of reporting, the events were resolved. The reporter''s assessment were not provided.


VAERS ID: 451177 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2008-04-29
Onset:2008-10-05
   Days after vaccination:159
Submitted: 2012-03-06
   Days after onset:1248
Entered: 2012-03-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS A20CA401A / 2 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 29837 / 3 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA563A / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Apathy, Barium enema, Crying, Gastrointestinal sounds abnormal, Intussusception, Pallor, Ultrasound scan abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Dementia (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad)

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, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Antipyretic; Tixocortol pivalate
Current Illness: Infection
Preexisting Conditions: Born at 37 weeks of amenorrhea, birth weight 3.23 kg. Mixed feeding with diversified diet. No relevant medical history.
Allergies:
Diagnostic Lab Data: Ultrasound scan, 05Oct 2008, suggestive of in
CDC Split Type: B0784247A

Write-up: This case was reported by a CRO during a prospective study (EPIstudy) and described the occurrence of intussusception in a 8-year-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject weighed 9.41 kg and measured 69 cm. He was born at 37 weeks of amenorrhea (birth weight 3.23 kg). He had mixed feeding with a diversified diet. Within the 15 days before the event, the subject had an ENT infection. He had no other relevant medical history. Concurrent vaccinations included a first dose of INFANRIX QUINTA (batch A20CA403A) and a first dose of PREVENAR (batch 28575) and a first dose of ROTARIX (batch A41CA526A) given on 26 March 2008, a second dose of INFANRIX QUINTA (batch A20CA401A) and a second dose of PREVENAR (batch 29837) given on 29 April 2008, a third dose of PENTAVAC (batch B2070-1) and a third dose of PREVENAR (batch 32080) given on 16 May 2008,. a first dose of ENGERIX B10 (batch AHBVB382CA) given on 18 June 2008, a second dose of ENGERIX B10 (batch AHBVB496BA) given on 10 July 2008. Within the 15 days before the event, the subject was treated with antipyretic (nos) and PIVALONE. On 29 April 2008, the subject received the second dose of ROTARIX (batch A41CA563A, route unknown). On 05 October 2008, the subject was admitted to emergency unit with pallor and vomiting without fever. There was no sign of malnutrition. Ultrasound scan results were suggestive of intussusception. At emergency unit, intussusception was reduced with barium enema. On the same day, the subject was transferred in pediatric surgery unit. On admission, the subject was treated with pallor, apathy, abnormal crying and vomiting. Physical examination evidenced abnormal gastrointestinal sound. Clinical course was favourable without surgery, the subject was discharged from hospital on 07 October 2008. On 15 July 2009, the subject received a booster dose of INFANRIX HEXA (batch A21CA553A). Brighton score was quoted at 1 by a scientific committee. At the time of reporting, the events were resolved. The reporter''s assessment was not provided.


VAERS ID: 451333 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Male  
Location: Foreign  
Vaccinated:2011-12-21
Onset:2011-12-21
   Days after vaccination:0
Submitted: 2012-03-08
   Days after onset:78
Entered: 2012-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Haematochezia, Intensive care, Intestinal operation, Intussusception, Ultrasound abdomen abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad)

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, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Ultrasound abdomen, 22Dec2011, invagination; X-ray, 22Dec2011, invagination
CDC Split Type: B0772201A

Write-up: This case was reported by a physician and described the occurrence of stomach pain in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was breastfed at the time of vaccination. On 21 December 2011 afternoon, the subject received 1st dose of ROTARIX (oral, batch number not provided). On 21 December 2011, 2 hours after vaccination with ROTARIX, the subject experienced stomach pain. The mother contacted the family doctor, who suggested to use paracetamol and wait. The subject started to vomit at 22:12 and the mother saw blood in the pampers. The subject was brought to the hospital for further checking and he was hospitalized at 2:48 on 22 December 2011. Ultrasound and radiogram have showed the invagination. The operation was performed the same morning (from 4:55 until 6:35). The subject stayed at the intensive care. The physician considered the events were clinically significant (or requiring intervention). On 22 December 2011, the events were resolved. On 27 December 2011, the subject was discharged from hospital in good condition). The subject''s parents decided not to continue with the second dose of ROTARIX and parents were suggested not to vaccinate the subject during the following two months. Follow-up information received on 8 March 2012; Additional information have been requested but could not be obtained. Therefore, this case has been closed.


VAERS ID: 452044 (history)  
Form: Version 1.0  
Age: 0.43  
Sex: Male  
Location: Foreign  
Vaccinated:2012-03-02
Onset:2012-03-07
   Days after vaccination:5
Submitted: 2012-03-16
   Days after onset:8
Entered: 2012-03-19
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA405AA / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Crying, Echography abnormal, Enema administration, Feeding disorder neonatal, Intussusception, Rhinorrhoea, X-ray with contrast lower gastrointestinal tract abnormal
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific inflammation (broad), Depression (excl suicide and self injury) (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: Transposition of the great vessels; Ventricular hypoplasia; Ventricular septal defect
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Echography: There were findings suggesting invagination of the intestine. Irrigoscopy confirmed intussusception of the intestine in the transverse colon. Intestinal regulation with high pressure enema was performed. The subject was hospitalized for observation.
CDC Split Type: B0787599A

Write-up: This case was reported by a physician and described the occurrence of invagination of intestine in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date, the subject received the 2nd dose of ROTARIX (oral, batch number not provided). On 6 March 2012, at an unspecified time after vaccination with ROTARIX, the subject experienced invagination of intestine and was admitted to the reporting physician''s hospital and received treatment the same day. On 08 March 2012, at the time of reporting, the subject was still in the hospital. His discharge was scheduled for the following day. At time of reporting the outcome of the event was unspecified. Additional information received on 09 March 2012. On 03 February 2012, the subject received the 1st dose of ROTARIX. On 02 March 2012, the subject received the 2nd dose of ROTARIX (1.5 ml, batch number was provided. On 07 March 2012, the subject had a small amount of a stool in the morning but did not have it thereafter. On 07 March 2012, at night, the subject cried hard. On 07 March 2012, at 20:00, the subject was fed with milk for the last time that night. On 7 March 2012, at 21:00, as the subject began to cry hard, milk feeding was attempted but he did not suckle, though he usually suckles. He had slight nasal discharge. On 07 March 2012, at 22:00, the subject was taken to the hospital. As he stopped crying and fell asleep spontaneously, he was taken back home tentatively on the day. On 08 March 2012, at 0:00, the subject was taken to the hospital again since he continued to cry hard and have no milk. Echography showed findings suggesting invagination of the intestine. Irrigoscopy confirmed intussusception of the intestine in the transverse colon. Intestinal regulation with high pressure enema was performed. The subject was hospitalized for observation. On 08 March 2012, in the morning, milk feeding was restarted. There was no particular problem. On 09 March 2012, the subject was discharged from hospital. At time of reporting the event invagination of intestine had improved. The outcome of the other events was unknown.


VAERS ID: 452444 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-03-26
Entered: 2012-03-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal mass, Echography abnormal, Enema administration, Intussusception, Melaena, Mucous stools
SMQs:, 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 (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: Echography, liquid and abdom
CDC Split Type: B0790502A

Write-up: This case was reported by a physician and described the occurrence of invagination of intestine in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). No relevant medical history was reported. One month before vaccination with ROTARIX, the subject was vaccinated with SYNFLORIX and INFANRIX-HEXA. On an unspecified date, the subject received 1st dose of ROTARIX (oral). On the same day, the subject also received meningococcal conjugated vaccine (unknown manufacturer and route of administration) which was reported as concomitant by the reporter. Both batch numbers were not provided. Seventy-two hours after vaccinated with ROTARIX, the subject experienced invagination of intestine, melena and mucus in stool (mucorrhea). The subject was hospitalised. An abdominal echography revealed a liquid and abdominal mass. After underwent a colon enema, the subject remained at the hospital for another 48 hours. At the time of reporting the events were resolved. Additional information has been requested.


VAERS ID: 453685 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Male  
Location: Foreign  
Vaccinated:2012-02-28
Onset:2012-03-01
   Days after vaccination:2
Submitted: 2012-04-13
   Days after onset:42
Entered: 2012-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA462AE / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Adenovirus test, Bacterial test negative, C-reactive protein increased, Colectomy, Crying, Culture stool negative, Faeces discoloured, Floppy infant, Fluid intake reduced, Gastrointestinal disorder, Gastrointestinal pain, General physical health deterioration, Haematochezia, Hypophagia, Intussusception, Laparotomy, Rotavirus test negative, Ultrasound abdomen abnormal, Ultrasound scan, Upper respiratory tract infection, Viral test negative, Vomiting, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (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), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Noninfectious diarrhoea (broad), 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, 168 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Sodium Fluoride
Current Illness: Hydrotrophy; Meckel''s Diverticulum; Plagiocephaly
Preexisting Conditions: Low Birth Weight
Allergies:
Diagnostic Lab Data: Adenovirus test, 06Mar2012, stool: negative; Body temperature, 05Mar2012, 37.1degC; C reactive protein, 05Mar2012, 2.41mg/dl; C-reactive protein, 07Mar2012, 12.62mg/dl; C-reactive protein, 07Mar2012, 13.18mg/dl; C-reactive protein, 09Mar2012, 6.44mg/dl; C-reactive protein, 11Mar2012, 1.47mg/dl; Heart rate, 05Mar2012, 129/min; Rotavirus test, 06Mar2012, stool: negative; Stool culture, 0Mar2012, sterile; Ultrasound scan, 05Mar2012, pathologic; White blood cell count, 09Mar2012, 6.810e3/ul; White blood cell count increas, 05Mar2012, 12.310e3/ul
CDC Split Type: D0074868A

Write-up: This case was reported by a Foreign regulatory authority (#DE-PEI-PEI2012007754) and described the occurrence of irreducible ileocolic intussusception in a 4-month-old male subject who was vaccinated with ROTARIX (liquid formulation, GlaxoSmithKline). Past medical history was not provided. On 28 February 2012 the subject received the first dose of ROTARIX (1.5 ml, oral). Approximately five days post vaccination with ROTARIX, on 04 March 2012, the subject experienced irreducible ileocolic intussusception. The subject was hospitalised for an unknown period of time. The event was assessed to be life threatening and to cause permanent damage. The event was confirmed by abdominal sonography. Gastroenteritis was excluded by differential diagnosis. Treatment included median laparotomy with surgical removal of intussusception by hemicolectomy. On the next day, on 05 March 2012, the event was resolved with sequelae (not further specified). Follow up information including a hospital report was received on 12 April 2012 from the Foreign regulatory authority. Medical history included low birth weight (small for gestational age: 38 +4 weeks, birth weight: 2125 g, length at birth: 44 cm, head circumference 22 cm), hypotrophy, plagiocephaly and a Meckel''s diverticulum without irritation. Concomitant medications included ZYMAFLUOR. On 28 February 2012 the subject received the first dose of ROTARIX liquid formulation (1.5 ml, oral). Less than one week post vaccination with ROTARIX liquid formulation, prior to or on 01 March 2012, the subject experienced signs and symptoms of gastrointestinal disorder including floppiness, multiple episodes of vomiting, reduced fluid and food intake, dark (cacao), coloured and blood stools, episode of whimpering and gastrointestinal pain. The subject experienced no fever. On 05 March 2012 the subject was hospitalised for about one week. On admission to hospital the subject was in reduced general condition. Lung and heart examinations were normal. Abdomen was soft, with resistance in the right mesegastric region and high positioned scarse bowel sounds. Inflammatory parameters, including white blood cell count and C reactive protein (CRP), were increased. Stool antigen tests for Rotavirus, Norovirus and Adenovirus, performed on 06 March 2012, were negative. Stool cultures for bacteria from the TPE (typhus-parathyphus-enteritis) or Salmonella group, including Salmonella sp., Shigella sp., Yersinia sp. and pathogenic Escherichia coli, performed on 07 March 2012, were sterile. The subject suffered from very severe gastrointestinal pain and discharged blood tinged stool. Abdominal sonography, performed on 05 March 2012, revealed imminent signs of intussusception. Conservative disinvagination / hydrostatis reduction with Ringer''s solution failed. Thus surgical reduction was indicated. Intraoperative disinvagination was also not successful. Therefore surgical reduction proved to be unfeasible so that hemicolectomy right had to be performed including removal of the ileocecal valve. A non irritant Meckel''s diverticulum was kept in place. Histology of a 30.5 cm long hemicolectomy sample with distinctly pronounced invagination in the area of the caecum, performed on 09 March 2012, revealed ischemic mucous membrane necrosis, follicular lymphatic hyperplasia and mesenteric lymphadenitis most likely in line with a viral infection. In addition to surgical intervention, the patient was treated with intravenous fluids with dextrose + electrolytes (electrolyte + glucose infusion) as well as antibiotic treatment with Metronidazol and Ceturoxim and analgesic treatment with Paracetamol and Piritramid. Oral nutrition build up was well tolerated and the subject showed good bowel movement. Since 10 March 2012 intravenous fluids were reduced and analgesic treatment was discontinued. Seven days post surgery antibiotic treatment was stopped. On 12 March 2012 surgical examination showed good progress of surgical wound healing. In addition to ileocolic intussusception the subject was diagnosed with upper respiratory tract infection was treated by inhalation therapy. The subject was discharged from hospital in good general condition with non irritant wound condition , good fluid intake and adequate weight gain for ambulatory follow-up. No further information will be available.


VAERS ID: 453836 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: Foreign  
Vaccinated:2011-12-28
Onset:2012-01-01
   Days after vaccination:4
Submitted: 2012-04-13
   Days after onset:102
Entered: 2012-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA405CA / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Alanine aminotransferase normal, Aspartate aminotransferase normal, Basophil percentage decreased, Blood albumin normal, Blood chloride normal, Blood creatine phosphokinase normal, Blood creatinine decreased, Blood lactate dehydrogenase increased, Blood potassium normal, Blood sodium normal, Blood urea normal, C-reactive protein normal, Enema administration, Eosinophil percentage decreased, Feeling abnormal, Gamma-glutamyltransferase normal, Haematochezia, Haemoglobin normal, Intussusception, Lymphocyte percentage, Monocyte percentage increased, Mood altered, Neutrophil percentage, Platelet count normal, Protein total decreased, Prothrombin level decreased, Prothrombin time normal, Red blood cell count normal, Soft tissue mass, Surgery, Ultrasound abdomen abnormal, Vomiting, White blood cell count normal, X-ray abnormal
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Acute pancreatitis (broad), Haematopoietic leukopenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Alanine aminotransferase, 03Jan2012, 20IU/L; Albumin, 03Jan2012, 4.2%; Aspartate aminotransferase, 03Jan2012, 23IU/L; Basophils, 03Jan2012, 0.2%; Bilirubin total, 03Jan2012, 0.4mg/dL; Blood pressure, 03Jan2012, 121/71mmHg; Blood urea nitrogen, 03Jan2012, 11.1mg/dL; Body temperature, 03Jan2012, 36.9deg. C.; C-reactive protein, 03Jan2012, 0.5mg/dL; Creatine phosphokinase, 03Jan2012, 86IU/L; Eosinophils, 03Jan2012, 0.0%; Gamma glutamyl transpeptidase, 03Jan2012, 21IU/L; Hemoglobin, 03Jan2012, 12.5g/dL; Lactate dehydrogenase, 03Jan2012, 262IU/L; Lymphocytes, 03Jan2012, 23.3%; Monocytes, 03Jan2012, 11.4%; Neutrophils, 03Jan2012, 65.1%; Platelet count, 03Jan2012, 37.1x10e4/mm3; Protein total, 03Jan2012, 5.8g/dL; Prothrombin, 03Jan2012, 84.8%; Prothrombin time, 03Jan2012, 12.5sec; Pulse rate, 03Jan2012, 144; Red blood cell count, 03Jan2012, 4.62cells/mm3; Serum chloride, 03Jan2012, 105mEq/L; Serum creatinine, 03Jan2012, 0.19mg/dL; Serum potassium, 03Jan2012, 4.1mEq/L; Serum sodium, 03Jan2012, 141mEq/L; White blood cells, 03Jan2012, 11000cells/mm3
CDC Split Type: B0781314A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccinations included combined diphtheria, tetanus, pertussis vaccine (manufacturer unspecified, subcutaneous, unknown injection site, batch number not provided), haemophilus influenza type B vaccine (non-GSK, subcutaneous, unknown injection site, batch number not provided) and pneumococcal vaccines (non-GSK, subcutaneous, unknown injection site, batch number not provided) given on 28 December 2011. On 28 December 2011, the subject received unspecified dose of ROTARIX (1.5 ml, oral). On 1 January 2012, 4 days after vaccination with ROTARIX, the subject experienced intussusception. From 2 January 2012 to 3 January 2012, the subject was hospitalised in a national medical center. From 3 January 2012 to 13 January 2012, the subject was hospitalised in a prefectural hospital, where he underwent a surgical operation. At the time of reporting the event was improved. The physician considered the event was related to vaccination with ROTARIX. Follow-up information received on 9 April 2012: The subject had no family history of intussusception of intestinal abnormality. The subject had no past medical history of intra-abdominal procedure, congenital intestinal malformation, intestinal polyp, Meckel''s diverticulum, intestinal vascular malformation, cystic fibrosis, Hirschsprung''s disease, other gastrointestinal malformation and malfunction or intussusception. On 1 January 2012, at 21:00, 4 days after vaccination with ROTARIX, the subject presented with feeling poorly and bad mood. On 2 January 2012, at 2:00, 5 days after vaccination with ROTARIX, vomiting developed. On 3 January 2012, at 3:00, 6 days after vaccination with ROTARIX, bloody stools developed. Visible intussusception or soft tissue mass and niveau and distended intestinal loops were confirmed on plain abdominal X-ray. Intussusception findings were confirmed with enema of air or contrast medium. Nonspecific abnormalities were not confirmed on plain abdominal X-ray. Visible intussusception or soft tissue mass and massive intra-abdominal findings with specific characteristics were confirmed on abdominal ultrasound. An abdominal CT scanning was not performed. Intraoperative signs of intussusception finding were confirmed on 3 January 2012. Enterectomy was not performed. The symptom did not disappear with enemas of contrast medium, hydrostatic pressure or air and it became necessary to have reduction surgery. However, resection was not performed as ablative surgery was not required. There was no complication with X-ray procedure or related to the surgery. The subject survived. At the time of reporting the intussusception was improved and the outcome of the other events was unspecified.


VAERS ID: 454343 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-25
Entered: 2012-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cytolytic hepatitis, Disseminated intravascular coagulation, Intestinal haemorrhage, Intestinal resection, Intussusception, Malaise, Somnolence, Urticaria
SMQs:, Hepatitis, non-infectious (narrow), Anaphylactic reaction (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), 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), Hypersensitivity (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0797791A

Write-up: This case was reported by a physician via the online forum of pediatrics and described the occurrence of hepatic cytolysis in an infant subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was an heterozygous twin. On an unspecified date, the subject received unspecified dose of ROTARIX (unknown route). 48 hours after vaccination with ROTARIX, the subject experienced malaise, drowsiness, enterorrhagia, and generalized urticaria. The diagnosis was intussusception, consumptive coagulopathy and markedly hepatic cytolysis. The subject was hospitalised. The subject underwent resection of the cecum and valve for intussusception. At the time of reporting the events were improved. The physician considered the events were possibly related to vaccination with ROTARIX.


VAERS ID: 454347 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Female  
Location: Foreign  
Vaccinated:2011-12-16
Onset:2011-12-21
   Days after vaccination:5
Submitted: 2012-04-25
   Days after onset:125
Entered: 2012-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA405AA / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal mass, Apathy, Enema administration, Gastroenteritis, Haematochezia, Injection site induration, Intussusception, Lymphadenopathy, Nausea, Ultrasound abdomen abnormal, Vomiting, X-ray normal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 22Dec2011, normal; Body temperature, 21Dec2011, 37.2deg C; Body temperature, 21Dec2011, 36.9deg C; Body temperature, 22Dec2011, 36.7deg C; Body temperature, 22Dec2011, 37.2deg C; Heart rate, 21Dec2011, 130bpm; Heart rate, 22Dec2011, 132bpm; Heart rate, 22Dec2011, 112bpm; Ultrasound scan, 21Dec2011, intussusception
CDC Split Type: B0797063A

Write-up: This case was reported by a physician and described the occurrence of invagination of intestine in a 20-week-old female subject who was vaccinated with ROTARIX (liquid formulation, GlaxoSmithKline). Concurrent vaccination included DTP vaccine (non-GSK manufacturer; subcutaneous) given on 16 December 2011; haemophilus influenzae type b vaccine (non-GSK manufacturer; subcutaneous) given on 16 December 2011; pneumococcal vaccines (non-GSK manufacturer; subcutaneous) given on 16 December 2011. Previously, the subject received these vaccinations without any reaction. On 16 December 2011 the subject received unspecified dose of ROTARIX liquid formulation (1.5 ml, oral). On 21 December 2011, 5 days after vaccination with ROTARIX liquid formulation, the subject experienced 2 episodes of vomiting did bloody stools. The subject was hospitalised for 2 days and invagination of intestine was diagnosed. The physician considered the events were disabling. The subject was treated with high pressure enema and improved. On 24 December 2011, the events were resolved. The physician considered the events were related to vaccination with ROTARIX liquid formulation. Follow up information received on 20 April 2012: On 21 December 2011, at 7:30, the subject vomited like a fountain after drinking approximately 70 mL of milk. The subject visited a nearby hospital, and was prescribed DOMPERIDONE suppository. At 15:00, the subject had large-volume vomiting after drinking approximately 110 mL of milk. Bloody stools was observed after insertion of Nauzelin suppository into the rectum. The subject was apathetic, and was referred to and visited the reporting physician''s department for suspected intussusception. At 17:30, at admission to the department, the subject was queasy and apathetic. A hard mass was palpable in the area from the right lower thigh to the upper abdomen. Ultrasonography of the area showed target sign, and ileo-ileo-colic intussusception was diagnosed. Reduction with high-pressure air enema was performed. The subject was admitted to the department for observation of the course. After admission, the subject started drinking milk, but no vomiting or abdominal pain occurred. On 22 December 2011, at 9:00, an abdominal X-ray showed no problems. Intussusception did not recur, and the subject was discharged from the department in good condition. The reporter considered the events were not disabling anymore. The reporter considered the intussusception was possibly related to ROTARIX and acute gastroenteritis. The possibility that the subject received the vaccines and enlargement of the mesenteric lymph nodes due to gastroenteritis developed at the same time, which caused the invagination of intestine, was considered as undeniable.


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