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Found 13 cases where Vaccine is RV1 and Symptom is Intussusception and Patient Died

Table

   
AgeCountPercent
< 3 Years1292.31%
Unknown17.69%
TOTAL13100%

Case Details

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VAERS ID: 309526 (history)  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2007-08-07
Onset:2007-11-21
   Days after vaccination:106
Submitted: 2008-04-15
   Days after onset:145
Entered: 2008-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 0 - / PO

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

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

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


VAERS ID: 311427 (history)  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2008-02-05
Onset:2008-02-08
   Days after vaccination:3
Submitted: 2008-05-02
   Days after onset:83
Entered: 2008-05-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR B21341 / 2 UN / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER BC56070 / 2 UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR B21341 / 2 UN / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR B21341 / 2 UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA402A / 1 - / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Ascites, Autopsy, Death, Gastrointestinal necrosis, Haematochezia, Intussusception, Skin discolouration, Small intestinal obstruction, Vomiting
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? Yes
   Date died: 2008-02-09
   Days after onset: 1
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Abdominal X-ray, 08Feb2008, fluid levelsunit
CDC Split Type: B0507296A

Write-up: This case was reported by a healthcare professional and described the occurrence of intussusception in a 3-month-old female subject who was vaccinated with Rotarix (GlaxoSmithKline). Previous and/or concurrent vaccination included Pentaxim, Sanofi Pasteur MSD (intramuscular; left thigh) given on 6 December 2007, 8 January 2008 and 5 February 2008; Heberboivac, Heber Biotec (intramuscular; right thigh) given on 6 December 2007, 8 January 2008; Rotarix (GlaxoSmithKline; oral) given on 8 January 2008. On 5 February 2008 the subject received 2nd dose of Rotarix (oral). The subject was healthy and responded well to previous vaccinations without experienced any adverse event. On 8 February 2008, 3 days after vaccination with Rotarix, the subject developed symptoms of bloody stools and vomiting. The subject was taken to the emergency room as the subject got worse. Relevant test included abdominal x-ray which showed dilated gas-filled bowel loops in central abdomen with fluid levels, gas visible in descending colon, obstruction of ileus, no visible air in bowel walls, heart and lung fields appear normal. The physician advised her admission but the subject''s parents apparently refused it. On 09 February 2008 the subject was taken back to hospital where resuscitation was started but the subject passed away on the same day at 9:00. The autopsy was being planned for the 12th February 2008. The subject died due to intussusception which was probably related to vaccination with Rotarix. Follow up received on 26 February 2008: After a phone communication the subject''s parents did not want to give a copy of the autopsy. The subject''s mother mentioned that all the documentation of the autopsy was frozen. According to the subject''s mother the autopsy report stated that the subject died due to obstruction of the ileum caused by the Rotarix. Follow up received on 22 April 2008: The autopsy report (performed on 12 February 2008) stated: Cause of death included bowel obstruction with intussusception and necrosis of the small bowel. Subject''s age: 3month-old and 17 days. Length: 60 cm. Mass approximately: 5 kg. Subject''s physique under average. Subject''s nutrition good. Secondary postmortem changes: rigor mortis. External appearance of body and condition of limbs: abdominal distention with blue discolouration of skin over abdomen. No external injuries visible. Trachea: no foreign object''s in trachea. Peritoneal cavity: abdominal distention and ascites. Intestine and mesentery: intussusception of small bowel with acute bowel obstruction and necrosis of small bowel. The medical certificate of death stated: Immediate cause: intestinal obstruction. Underlying cause: intussusception.


VAERS ID: 326697 (history)  
Age: 0.4  
Gender: Male  
Location: Foreign  
Vaccinated:2008-02-18
Onset:2008-02-28
   Days after vaccination:10
Submitted: 2008-10-01
   Days after onset:215
Entered: 2008-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 - / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal pain, Activated partial thromboplastin time shortened, Blood calcium normal, Blood creatinine normal, Blood glucose increased, Blood group O, Blood potassium increased, Blood sodium normal, Blood urea increased, Bradycardia, Bradypnoea, Cardio-respiratory arrest, Cyanosis, Death, Decreased activity, Dehydration, Grand mal convulsion, Haematochezia, Haematocrit decreased, Haemoglobin normal, Hyponatraemia, Hypovolaemic shock, Ileostomy, Ileus paralytic, Intestinal anastomosis, Intestinal dilatation, Intestinal obstruction, Intestinal resection, Intussusception, Irritability, Metabolic disorder, Pain, Pharyngeal erythema, Platelet count increased, Prothrombin time shortened, Pyrexia, Rales, Rectal haemorrhage, Respiratory distress, Resuscitation, Rhesus antibodies positive, Status epilepticus, Surgery, Tachycardia, Vomiting, White blood cell count increased, X-ray abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Acute renal failure (broad), Haemolytic disorders (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Convulsions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Died? Yes
   Date died: 2008-03-15
   Days after onset: 15
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cough, Meckel diverticulum
Preexisting Conditions:
Diagnostic Lab Data: Abdominal X-ray, 02Mar2008, see textunit; Abdominal X-ray, 08Mar2008, see textunit; Abdominal X-ray, 12Mar2008, see textunit; Blood glucose, 02Mar2008, 94mg/dl; Blood grouping, 02Mar2008, ORh+; Calcium, 02Mar2008, 9.2mEq/l; Creatinine, 02Mar2008, 0.8mg/dl; Hematocrit, 02Mar2008, 34.6%; Hemoglobin, 02Mar2008, 11.6mg/dl; Leukocyte count NOS, 02Mar2008, 20470mm3; Partial thromboplastin time pr, 02Mar2008, 29..9s; Platelet count, 02Mar2008, 710000mm3; Potassium, 02Mar2008, 5.8mEq/l; Prothrombin time, 02Mar2008, 10.6s; Sodium, 02Mar2008, 134mEq/l; Urea, 02Mar2008, 62.6mg/dl
CDC Split Type: B0538764A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 4month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent medical conditions included Meckel diverticulum. Previous and/or concurrent vaccination included ROTARIX; GlaxoSmithKline; oral given on 13 December 2007. Six days before hospital admission the subject had cough. On 18 February 2008 the subject received 2nd dose of ROTARIX (oral). On 28 February 2008, 10 days after vaccination with ROTARIX, the subject experienced vomiting (10 episodes) abdominal distention and fever. On 02 March 2008 the subject was admitted at the emergency room presenting hypo activity, hyperemic pharynx, tachycardia, fever, abdominal pain with distention, dehydration, rectal tact with expulsion of fresh bloody stool and rectal bloody. The same day relevant test included abdominal x-ray showing intestinal occlusion and intussusception. Therefore the subject underwent a surgery which revealed Ileo Ileocolic intussusception with a necrotic mass (Meckel diverticulum considered congenital anomaly) and 300 cc of peritoneal free liquid. Intestinal resection of 10 cm was made with term to term anastomosis without further surgical correction. However the subject had unfavorable clinical evolution. He presented epileptic status with general tonic clonic seizures, hyponatremia and hypovolemic shock. On 08 March 2008 the subject showed abdominal distention. The same day the abdominal x-ray showed lack of intestinal air and rectal ampoule. The subject underwent again a surgery which showed intestinal occlusion, dysfunctional term to term anastomosis, damaged ileum and 100 cc of peritoneal liquid. A terminal ileum resection was required with a new ileal anastomosis. Post surgical evolution of the 2nd surgery was favorable for 2 days. On 11 March 2008 the subject presented irritability, abdominal distention, painfulness palpation and gastrobiliar liquid flow by nasogastric tube. Abdominal X-ray showed absence of intestinal air and air fluid levels. On 13 March 2008 the subject underwent a 3rd surgery which showed paralyzed colon, big intestinal dilatation of ileum and jejunum. The last anastomosis of the 2nd surgery was occluded in 90% of the lumen, loop to loop bridas, 60 cc of free serohematic liquid in abdominal cavity, bridas lysis, loops decompression and ileostomy of 2 stomas. The subject was discharged of surgery in favorable conditions. However on 14 March 2008 the subject presented crackles and slight respiratory distress without fever or infection evidence. On 15 March 2008 the subject had suddenly alveolar crackles in both lungs, cyanosis, bradycardia, bradypnea and finally cardio pulmonary arrest without response to resuscitation for 50 minutes. The physician considered the events were disabling, life threatening. The subject was treated with surgery, ceftriaxone, metamizole, metronadizole, vancomycin, omeprazole, THIOPENTAL, diazepam, phenytoin, clindamycin, metoclopramide, octreotide, salmeterol xinafoate, dexamethasone, dopamine, albumin, insulin, FUROSEMIDE, KETOROLAC and blood. The physician considered the events were possibly related to vaccination with ROTARIX. On 15 March 2008 the subject died from intestinal obstruction, intussusception and metabolic disorder.


VAERS ID: 385407 (history)  
Age: 0.34  
Gender: 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 - / 1 - / 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
Died? Yes
   Date died: 2009-10-05
   Days after onset: 0
Permanent Disability? No
Recovered? 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
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: 392108 (history)  
Age: 0.19  
Gender: Male  
Location: Foreign  
Vaccinated:2006-09-26
Onset:2006-10-03
   Days after vaccination:7
Submitted: 2010-07-06
   Days after onset:1372
Entered: 2010-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 0 - / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Abdominal pain, Death, Haematochezia, Intussusception, Rectal haemorrhage, Sepsis, Surgery, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Agranulocytosis (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
Died? Yes
   Date died: 2006-10-06
   Days after onset: 3
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: X-ray, 04Oct2006, IS
CDC Split Type: B0662987A

Write-up: This case was reported by a healthcare professional via another manufacturer (Fiocruz) and described the occurrence of intussusception in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 26 September 2006, the subject received 1st dose of ROTARIX (oral, lot number not provided). On 3 October 2006, 7 days after vaccination with ROTARIX, the subject experienced vomiting, abdominal pain, rectal bleeding, bloody stools and abdominal distension which leaded to medical care. On 3 October 2006, the subject was hospitalised. On 4 October 2006, X-ray suggested intussusception leading to surgery without resection. Sepsis leaded to death on 06 October 2006. Cause of death was not reported. It was unknown whether an autopsy was performed.


VAERS ID: 422813 (history)  
Age: 0.44  
Gender: Unknown  
Location: Foreign  
Vaccinated:2010-07-12
Onset:2010-07-15
   Days after vaccination:3
Submitted: 2011-05-12
   Days after onset:301
Entered: 2011-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPH: DTAP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / PO
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS XROLA102A1 / 1 - / PO

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

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

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


VAERS ID: 431419 (history)  
Age: 0.19  
Gender: Male  
Location: Foreign  
Vaccinated:2010-12-30
Onset:2011-03-25
   Days after vaccination:85
Submitted: 2011-08-25
   Days after onset:153
Entered: 2011-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS QROLA175A / - - / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Computerised tomogram, Constipation, Death, Intestinal dilatation, Intussusception, Septic shock, Surgery
SMQs:, Acute pancreatitis (broad), Agranulocytosis (broad), Toxic-septic shock conditions (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Died? Yes
   Date died: 2011-04-04
   Days after onset: 10
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Computerized tomogram, 2011, see text units
CDC Split Type: B0741901A

Write-up: This case was reported by a healthcare professional via another manufacturer (Fiocruz) and described the occurrence of septic shock in a 4-month-old male subject who was vaccinated with ROTARIX (Fiocruz). On 30 December 2010, the subject received unspecified dose of ROTARIX (oral). On 25 March 2011, 85 days after vaccination with ROTARIX, the subject experienced abdominal distension and stop of stool elimination. There was no vomiting. The subject underwent surgery with intussusception reduction, with no bowel perforation. The RX showed an important bowel distension. The subject was treated with ampicillin, GENTAMICIN, metronidazole and surgery. The subject died on 4 April 2011 from septic shock. It was unknown whether an autopsy was performed.


VAERS ID: 483937 (history)  
Age: 0.34  
Gender: Male  
Location: Foreign  
Vaccinated:2012-05-28
Onset:0000-00-00
Submitted: 2013-02-08
Entered: 2013-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS QROLA44AA / 1 - / PO

Administered by: Other       Purchased by: Other
Symptoms: Death, Enterocolitis, Intussusception, Peritonitis, Septic shock
SMQs:, Agranulocytosis (broad), Toxic-septic shock conditions (narrow), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal perforation (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (broad)

Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0865631A

Write-up: This case was reported by other health professional (National Immunization Program) and described the occurrence of intussusception of intestine in a 6-month-old male subject who was vaccinated with live ROTARIX (GlaxoSmithKline). On 28 May 2012, the subject received 2nd dose of ROTARIX (oral). In 2012, at an unspecified time after vaccination with ROTARIX, the subject experienced intussusception of intestine, septic shock, peritonitis and enterocolitis. The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention). The subject died from enterocolitis, intussusception of intestine, peritonitis and septic shock. It was unknown whether an autopsy was performed. This report is one of 800 cases received as part of a line-listing, each containing minimal information. No further information is expected.


VAERS ID: 483986 (history)  
Age: 0.17  
Gender: Female  
Location: Foreign  
Vaccinated:2012-02-23
Onset:2012-03-01
   Days after vaccination:7
Submitted: 2013-02-11
   Days after onset:347
Entered: 2013-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS QROLA350BA / 0 - / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Cardio-respiratory arrest, Death, Hypovolaemic shock, Intussusception, Multi-organ failure, X-ray abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Gastrointestinal obstruction (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Abdominal X-ray, Handles distenti
CDC Split Type: B0865673A

Write-up: This case was reported by a health professional and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 23 February 2012, the subject received 1st dose of ROTARIX (oral). At an unspecified time after vaccination with ROTARIX, the subject experienced intussusception, cardiorespiratory arrest, hypovolemic shock and multiple organ dysfunction. The subject was hospitalised and the regulatory authority reported that the events were clinically significant (or requiring intervention). An abdominal X-ray confirmed intussusception and showed handles distention. The subject died from cardiorespiratory arrest, hypovolemic shock, intussusception and multiple organ dysfunction. It was unknown whether an autopsy was performed. This report is one of 800 cases received as part of a line-listing, each containing minimal information. No further information was expected. Case was closed.


VAERS ID: 545049 (history)  
Age: 0.17  
Gender: Male  
Location: New York  
Vaccinated:2014-08-26
Onset:2014-09-12
   Days after vaccination:17
Submitted: 2014-09-18
   Days after onset:6
Entered: 2014-09-24
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4724AA / 0 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H65735 / 0 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FB434A / 0 - / PO

Administered by: Private       Purchased by: Private
Symptoms: Crying, Death, Disseminated intravascular coagulation, Dyspnoea, Enema administration, Food intolerance, Haematochezia, Intussusception, Irritability, Lethargy, Shock, Ultrasound abdomen abnormal
SMQs:, Anaphylactic reaction (narrow), 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), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Ischaemic colitis (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? Yes
   Date died: 2014-09-15
   Days after onset: 3
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Hyoscyamine sulfate prescribed 9/12/14
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Abdominal US 9/14/14 confirmed intussusception
CDC Split Type:

Write-up: Fussiness and crying onset 9/12/14 early AM, blood in stool that AM. More lethargic 9/13/14, not tolerating feeds. Seen in Emergency Room 9/13/14 - 9/14/14 - diagnosed with right upper quadrant intussusception reduced with air enema. Symptoms of shock, disseminated intravascular coagulation, third spacing of fluid, difficulty ventilating and ultimate death on 9/15/14.


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