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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: 311427 (history)  
Form: Version 1.0  
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 / 3 UN / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER BC56070 / 3 UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR B21341 / 3 UN / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR B21341 / 3 UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA402A / 2 MO / 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
Birth Defect? No
Died? Yes
   Date died: 2008-02-09
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
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: 311428 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2008-01-03
Onset:2008-02-09
   Days after vaccination:37
Submitted: 2008-05-02
   Days after onset:82
Entered: 2008-05-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Intestinal resection, Intussusception, Surgery, Ultrasound abdomen abnormal
SMQs:, Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray 09Feb2008 see text unit; Ultrasound abdomen 09Feb2008 see text unit.
CDC Split Type: B0509214A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX, GlaxoSmithKline. Previous vaccination included INFANRIX HEXA, GlaxoSmithKline; intramuscular, 1st dose left low inferior member given on 4 December 2007; PREVENAR; Wyeth Labs; intramuscular, 1st dose; right low inferior member given on 4 December 2007. On 3 January 2008 the subject received 1st dose of ROTARIX (oral). On 08 February 2008 the subject received the second dose of INFANRIX HEXA and PREVENAR. On 9 February 2008, 37 days after vaccination with ROTARIX, the subject experienced intussusception. The subject was hospitalised and the physician considered the event was life threatening and clinically significant (or requiring intervention). Relevant test results included abdominal x-ray which showed fluid levels and dilated bowel loops and the abdominal ultrasound showed a visible intussusception or soft tissue mass. The subject was treated with surgery on 10 February 2008. Intussusception was demonstrated at surgery. The subject required bowel resection. It was reported that complications occurred at radiological procedure but no details were provided. At the time of reporting the outcome of the event was unspecified. The physician considered the event was almost certainly related to vaccination with ROTARIX. In the follow up received on 25 April 2008 it was mentioned that the physician did not report and signs nor symptoms. Besides it was clarified that the complication at radiological procedure was an intestinal track perforation. On 15 April 2008 the subject was fully recovered.


VAERS ID: 311430 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Male  
Location: Foreign  
Vaccinated:2008-03-24
Onset:2008-03-24
   Days after vaccination:0
Submitted: 2008-05-02
   Days after onset:39
Entered: 2008-05-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Barium enema, Blood chloride increased, Blood creatinine normal, Blood glucose increased, Blood potassium normal, Blood sodium normal, Crying, Gastrointestinal sounds abnormal, Haematochezia, Haematocrit normal, Haemoglobin normal, Intussusception, Neutrophil percentage increased, Platelet count decreased, Vomiting, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), 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), Tubulointerstitial diseases (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? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: BRONCHIOLITIS
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 25Mar2008, see textunit; Blood glucose, 25Mar2008, 113mg/dl; Chloride, 25Mar2008, 110mEq/L; Creatinine, 25Mar2008, 0.4mg/dl; Hematocrit, 25Mar2008, 33.05%; Hemoglobin, 25Mar2008, 10.83g/dl; Leukocyte count NOS, 25Mar2008, 25140mm3; Neutrophils, 25Mar2008, 78.3%; Platelet count, 25Mar2008, 244800mm3; Potassium, 25Mar2008, 4.4mEq/L; Sodium, 25Mar2008, 143mEq/L
CDC Split Type: B0517772A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 4-month-old male subject who was vaccinated with Rotarix (GlaxoSmithKline). Previous and/or concurrent vaccination included DTaP-IPV-Hib; manufacturer unspecified; intramuscular given on 24 March 2008; Rotarix; GlaxoSmithKline; oral given on 8 January 2008. The subject''s medical history included bronchiolitis which occurred 3 weeks previous vaccination. The subject was hospitalised with good clinical evolution. No further information was available in the clinical file. On 24 March 2008 the subject received 2nd dose of Rotarix (oral). On 24 March 2008, less than one day after vaccination with Rotarix, the subject started vomiting and he had one stool like current jelly stool. The subject was treated with paracetamol and cisapride without improvement. On 25 March 2008 the subject was admitted at the emergency room with still vomiting and hematochezia. At physical examination the subject presented increasing bowel sounds and intense crying at abdominal palpation without evidence of respiratory process. Relevant test included abdominal x-ray which showed evidence of air fluid levels and lack of air in distal area. The barium enema showed invagination in ascendant colon in the first image, after that, it passed contrast medium until distal ileum successfully. The subject''s clinical evolution was favorable. On 27 March 2008 the subject was discharged in good clinical conditions. The subject was treated with Ketorolac, amikacin, ceftriaxone, nalbuphine and enema. The physician considered the events were possibly related to vaccination with Rotarix.


VAERS ID: 311431 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2007-09-11
Onset:2008-02-23
   Days after vaccination:165
Submitted: 2008-05-02
   Days after onset:68
Entered: 2008-05-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Barium enema abnormal, Dehydration, Diarrhoea, Haematochezia, Hyperaemia, Intestinal anastomosis, Intussusception, Pallor, Surgery, Vitello-intestinal duct remnant, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Congenital, familial and genetic disorders (narrow), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Dehydration (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, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray 26Feb2008 Abnormalunit; Barium enema 26Feb2008 Abnormalunit
CDC Split Type: B0518050A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 9-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was under no other medication and had no relevant medical history nor allergy. Previous and/or concurrent vaccination included attenuated human rotavirus vaccine ;GlaxoSmithKline ;oral given on 11 July 2007. On 11 September 2007, the subject received 2nd dose of ROTARIX (oral), lot number not provided. On 23 February 2008, 5 months after vaccination with 2nd dose of ROTARIX, the subject experienced bloody stools like current jelly stool with liquid diarrhea and vomiting. On 26 February 2008, the subject was hospitalised for 6 days. The physical examination showed pallor with dehydration, pharyngeal hyperemia and abdominal distension without peristalsis. The abdominal X-ray revealed dilated bowel loops with air fluid levels and lack of air in the distal colon. Barium enema was performed three times and showed a filling defect in the transverse colon, without a successful desinvagination. A surgery was performed and an ileocecocolic intussusception was found and reduced by taxis without complication. Furthermore, meckel diverticulum was observed in the distal ileon. The subject was treated with ceftriaxone, Ranitidine and Metamizole. ON 2 March 2008, the events were resolved and the subject was discharged from hospital in good clinical condition. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 311432 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Female  
Location: Foreign  
Vaccinated:2007-12-26
Onset:2008-02-15
   Days after vaccination:51
Submitted: 2008-05-02
   Days after onset:76
Entered: 2008-05-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal mass, Appendicectomy, Haematochezia, Haematocrit decreased, Haemoglobin decreased, Intussusception, Lymphocyte count increased, Neutrophil count decreased, Surgery, Vomiting, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (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? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray 18Feb2008 see textunit; Hematocrit 18Feb2008 33%; Hemoglobin 18Feb2008 11.3g/dl; Leukocyte count NOS 18Feb2008 11500mm3; Lymphocytes 18Feb2008 59.5%; Neutrophils 18Feb2008 32.6%
CDC Split Type: B0518480A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 6-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous vaccination included live attenuated human rotavirus vaccine; GlaxoSmithKline; given on 25 October 2007. The subject was on no other medication and had no relevant medical history nor allergy. On 26 December 2007 the subject received 2nd dose of ROTARIX (oral). On 15 February 2008, 51 days after vaccination with ROTARIX, the subject started with continuous vomiting (10 episodes per 24 hours) and bloody stools (2 episodes per 24 hours). Therefore the subject was taken to the emergency room. Subject''s physical examination showed no dehydration, mild abdominal distension, abdominal mass in epigastrium, hypoactive peristalsis, bloody stools at rectal examination. Relevant test includes abdominal x-ray which showed distended loops without gas in rectum. On 18 February 2008 the subject was hospitalised and the same day the subject underwent a surgery. Ileocecocolic intussusception was resolved by taxis and also appendectomy was done. The subject''s clinical evolution was improved. On 25 February 2008 the subject was discharged without any complication. The subject was treated with amikacin, metronidazole (Metronidazol), ranitidine hydrochloride (Ranitidine), dipyrone (Metamizol) and surgery. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 311730 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2008-03-18
Onset:2008-04-05
   Days after vaccination:18
Submitted: 2008-05-06
   Days after onset:31
Entered: 2008-05-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal mass, Appendicitis, Convulsion, Dehydration, Gastrointestinal necrosis, Haematochezia, Hyperaemia, Intestinal resection, Intussusception, Irritability, Peristalsis visible, Pharyngotonsillitis, Purulent discharge, Pyrexia, Rectal haemorrhage, Rhinorrhoea, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Agranulocytosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), 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 infections (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (narrow), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (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, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Apr2008 Abdominal X-ray was performed and showed bad distribution of air and distal absence. Plain abdominal radiograph showed fluid levels, dilated bowel loops and non-specific abnormalities. Plain abdominal radiograph did not show a visible intussusception or soft tissue mass.
CDC Split Type: B0517774A

Write-up: This case was reported by a physician and described the occurrence of invagination of intestine in a 4-month-old female subject who was vaccinated with Rotarix (GlaxoSmithKline). The subject had no family history of intussusception or bowel abnormalities. The subject had no history of the following: previous intra-abdominal surgery, congenital intestinal malformation, intestinal polyps, Meckels diverticulum, intestinal vascular malformations, cystic fibrosis, Hirschsprung disease, other gastrointestinal malformation and dysfunction or intussusception. Previous and/or concurrent vaccination included DTap-IPV-HIB (manufacturer unspecified; intramuscular; unknown) given on 15 February 2008; Hep B (manufacturer unspecified; intramuscular; unknown) given on 15 November 2007 and 15 January 2008; pneumococcal vaccine, unspecified (manufacturer unspecified; intramuscular; unknown) given on 15 February 2008; tuberculosis vaccine (GlaxoSmithKline; intradermal; unknown) given on 15 November 2007. On 18 March 2008 and 15 January 2008, the subject received the 2nd dose and the 1st dose of Rotarix (oral). On unspecified date (one week before admission), at an unspecified time after vaccination with Rotarix, the subject started with hyaline rhinorrhea and fever with good response after receiving non specific treatment. However on 05 April 2008 she presented generalized seizures, reason why she was admitted to hospital, at the same time she started with bloody stools. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). Physical examination reported dehydration, irritability, pharyngotonsillitis with hyperemia, purulent exudates without no respiratory difficulty or meningeal irritation, non-tender abdomen, normal peristalsis, only rectal bleeding was observed and gastrobiliary vomiting. On left abdomen a pain-palpable mass (Morcilla and Dance signs) was found. Abdominal X-ray was performed and showed bad distribution of air and distal absence. Plain abdominal radiograph showed fluid levels, dilated bowel loops and non-specific abnormalities. Plain abdominal radiograph did not show a visible intussusception or soft tissue mass. The subject required intervention on 06 April 2008 suspecting intestinal invagination and corroborating that it was ileocecal IS with complications appendiceal necrosis, cecal, ascendant colon and 5 cm of ileum. A resection of necrotic structures was performed without complications. The subject had good clinical response, with no infections or seizures. Neuro infection was discarded. The subject had good response to PO, normal evacuations and he was finally discharged on 12 April 2008 in good clinical conditions. On 12 April 2008, the events were resolved. The physician considered the events were unrelated to vaccination with Rotarix.


VAERS ID: 312272 (history)  
Form: Version 1.0  
Age: 0.25  
Gender: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-05-13
Entered: 2008-05-13
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: B0504877A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 3.5-month-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline) for prophylaxis. On an unspecified date the subject received the 1st dose of ROTARIX (oral). Eight days after vaccination with the 1st dose of ROTARIX, the subject experienced intussusception. The physician considered the event was clinically significant (or requiring intervention). At the time of reporting the outcome of the event was unspecified. Follow up information received on 01 May 2008: the subject''s age is 3.5 months instead of years as initially reported. Further information has been requested (Targeted Follow-Up Questionnaire for intussusception), but it was impossible to obtain additional details from the reporter as she did not recall any more data of the event so as to complete the form; this case has been therefore considered closed.


VAERS ID: 312275 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:2008-02-26
Onset:2008-03-01
   Days after vaccination:4
Submitted: 2008-05-13
   Days after onset:72
Entered: 2008-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal mass, Abdominal pain, Blood calcium decreased, Blood potassium increased, Blood sodium normal, Gastrointestinal hypomotility, Gastrointestinal tube insertion, Haematochezia, Haematocrit decreased, Haemoglobin decreased, Intestinal perforation, Intestinal resection, Intussusception, Lymphocyte count decreased, Mucous stools, Platelet count normal, Surgery, Vomiting, White blood cell count increased, X-ray abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal perforation (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray 02Mar2008 See text; Calcium 06Mar2008 7.5mEq/L 8.8 (low) 11.2 (high); Hematocrit 02Mar2008 30.7% 29 (low) 42 (high); Hemoglobin 02Mar2008 9.6g/dl 10 (low) 13 (high); Lymphocyte percentage 02Mar2008 18% 41 (low) 71 (high); Platelet count 02Mar2008 179000/mm3 300000 (low) 700000 (high); Potassium 06Mar2008 5.9mEq/L 3.5 (low) 4.5 (high); Sodium 06Mar2008 141mEq/L 135 (low) 145 (high); White blood cell count 02Mar2008 18700/mm3 10000 (low) 15000 (high)
CDC Split Type: B0519415A

Write-up: This case was reported by a physician in the time frame of a study and described the occurrence of intussusception in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history or allergies. Concurrent vaccination included DTPa-IPV-HIB (manufacturer unspecified; intramuscular; unknown) given on 26 February 2008; hepatitis B vaccine recombinant (manufacturer unspecified; intramuscular; unknown) given on 26 February 2008 and pneumococcal vaccine, unspecified (manufacturer unspecified; intramuscular; unknown) given on 26 February 2008. On 26 February 2008 the subject received the 1st dose of ROTARIX (oral). On 1 March 2008, 4 days after vaccination with the 1st dose of ROTARIX, the subject experienced 4 vomiting, mucosanguinolent stools and abdominal distension. The subject was hospitalized. On 2 March 2008, laboratory tests were performed and showed the following: Hemoglobin 9.6 g/dL (normal range: 10-13); Leucocytes count: 18700/mm3 (normal range: 10000-15000); Platelets count: 179000/mm3 (normal range: 300000-700000); Hematocrit: 30.7% (normal range: 29-43); Lymphocytes percentage: 18% (normal range: 41-71). Abdominal X-ray was performed and showed big distension of intestinal loops and lack of air in rectal ampulla. Intussusception was suspected. The subject was sent to another hospital with pediatric attention. She was admitted at this hospital on 04 March 2008 with dates of more abdominal distension, nasogastric tube with billar material drainage, diminished peristalsis, painful abdominal mass on left side and more sanguinolent stools. Surgery was performed on 04 March 2008; intussusception in ileocecocolic position was found with small perforation (2cm). Resection of ischemic segment with term to term anastomosis (ileal-transverse-colon) was done without complication. After that the subject showed good recuperation without sepsis or complications. On 6 march 2008, laboratory tests were performed and showed the following: Sodium: 141 mEq/L (normal range: 135-145); Potassium: 5.9 mEq/L (normal range: 3.5-4.5); Calcium: 7.5 mEq/L (normal range: 8.8-11.2). On 11 March 2008, finally oral acceptance started. On 14 March 2008, the subject was discharged in good clinical condition without sequels. The subject was treated with Ranitidine, Amikacine, Ampicillin, Metamizole, nalbuphine, buprenorphine, Ketorolac, paracetamol, cefotaxime and metronidazole. On 14 March 2008, the events were resolved. The physician considered the events were disabling and life threatening. The physician considered the events were possibly related to vaccination with ROTARIX.


VAERS ID: 312402 (history)  
Form: Version 1.0  
Age: 0.5  
Gender: Female  
Location: Foreign  
Vaccinated:2008-03-14
Onset:2008-04-29
   Days after vaccination:46
Submitted: 2008-05-15
   Days after onset:16
Entered: 2008-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal pain, Abdominal tenderness, Appendicectomy, Body temperature increased, Gastrointestinal hypomotility, Haematochezia, Intussusception, Pyrexia, Surgery, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (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, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray 30Apr2008 see text unit; Body temperature 29Apr2008 38.8deg C
CDC Split Type: B0519432A

Write-up: This case was reported by a physician in the frame of a PASS study and described the occurrence of intussusception in a 7-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous vaccination included live attenuated human rotavirus vaccine; GlaxoSmithKline; oral given on 15 January 2008. On 14 March 2008 the subject received 2nd dose of ROTARIX (oral). On 29 April 2008, 46 days after vaccination with ROTARIX, the subject presented abdominal pain, vomiting (2 episodes), bloody stools (2 times) and fever. On 30 April 2008 the subject was taken to the emergency room. Physical examination included fever 38.8 deg C, tender abdomen with decreased peristalsis and no abdominal mass. She had bloody stool in her diaper. Relevant test included abdominal x-ray which showed distended loops in upper left quadrant. The same day the subject underwent surgery in which ileoceco-colic intussusception was confirmed and resolved by taxis. Also appendectomy was done. The event was resolved without complication and good clinical evolution. On 02 May the subject was discharged in good condition. The subject was treated with metronidazole, amikacin and ranitidine hydrochloride (Ranitidine). The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 312607 (history)  
Form: Version 1.0  
Age: 0.5  
Gender: Female  
Location: Foreign  
Vaccinated:2008-02-05
Onset:2008-03-12
   Days after vaccination:36
Submitted: 2008-05-19
   Days after onset:68
Entered: 2008-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Blood creatinine increased, Blood potassium decreased, Blood sodium normal, Dehydration, Diarrhoea, Grand mal convulsion, Haematochezia, Haematocrit normal, Haemoglobin decreased, Intussusception, Malaise, Nervous system disorder, Neutrophil percentage increased, Pallor, Platelet count normal, Stool analysis normal, Vomiting, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Convulsions (narrow), 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), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Hemoglobin: 10.9 g/dL (normal range: 10.0-13.0); Hematocrit: 32.7 % (normal range: 29-42); Platelets count: 489000/mm3 (normal range: 300000-700000); Neutrophils: 75.5% (normal range: 13-33); Sodium 143 mEq/L (normal range: 135-145); Potassium: 4.3 mEq/L (normal range: 3.7-5.5). On 15 March 2008, laboratory tests were performed and showed the following: Hemoglobin: 6 g/dL (normal range: 10.0-13.0); Potassium: 2.1 mEq/L (normal range: 3.5-5.5). On 19 March 2008, laboratory tests were performed and showed the following: Sodium: 141 mEq/L (normal range: 135-145); Potassium: 5.2 mEq/L (normal range: 3.5-5.5); Chloride: 105 mEq/L (normal range: 95-105); Creatinine: 0.15 mEq/L (normal range: 0.1-0.6); Prothrombin Time: 13.5 seconds (normal range: 10.1-15.9); Pratial Thromboplastine Time: 31.3 seconds (normal range: 31.3-54). On 03 April 2008, laboratory tests were performed and showed the following: Hemoglobin: 10.8 g/dL (normal range: 10.0-13.0); leucocytes: 14540/mm3 (normal range: 6000-17500); Neutrophils: 60% (normal range: 13-33); Platelets count: 504000/mm3 (normal range: 300000-700000).
CDC Split Type: B0520189A

Write-up: This case was reported by a physician in the frame of a PASS study and described the occurrence of intussusception in a 7-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previously, the subject was healthy. Previous vaccination included ROTARIX (GlaxoSmithKline; oral) given on 6 December 2007. On 5 February 2008, the subject received the 2nd dose of ROTARIX (oral). On 12 March 2008, 36 days after vaccination with the 2nd dose of ROTARIX, the subject experienced oral intolerance, gastroalimentary vomiting, then biliar and one liquid stool. The subject was hospitalised on ER (date of hospitalisation was not available in the chart). The subject showed 11 "mucosanguinolent" stools, malaise, pallor, abdominal distension, dehydration and most severe conditions. Laboratory tests were performed and showed the following: Hemoglobin: 10.9 g/dL (normal range: 10.0-13.0); Hematocrit: 32.7 % (normal range: 29-42); Platelets count: 489000/mm3 (normal range: 300000-700000); Neutrophils: 75.5% (normal range: 13-33); Sodium 143 mEq/L (normal range: 135-145); Potassium: 4.3 mEq/L (normal range: 3.7-5.5). Entamoeba histolytica test (fresh stool) was performed and was negative. The subject was sent to another hospital with surgical pediatric attention. On 15 March 2008, at physical exam, the subject showed severe dehydration, pallor, malaise, tonic-clonic generalized convulsions, neurological deterioration, abdominal zone with distension, pain, without palpable mass, expulsion of current jelly stool and delayed capillary filling. No abdominal x-ray was reported in the clinical file. On 15 March 2008, laboratory tests were performed and showed the following: Hemoglobin: 6 g/dL (normal range: 10.0-13.0); Potassium: 2.1 mEq/L (normal range: 3.5-5.5). On 15 March 2008, the subject received the first transfusion of globular package (86ml) without complication. On 15 March 2008, surgery was performed; intussusception ileo-ceco-colic was found with large invagination up to descendent colon with ischemic intestinal . Ten minutes after, the subject showed recuperation. For this reason resection was not done. On 15 March 2008, after surgery, the subject received transfusion of globular package (160 ml). The subject received also frozen plasma (90ml) without complication. On 19 March 2008, laboratory tests were performed and showed the following: Sodium: 141 mEq/L (normal range: 135-145); Potassium: 5.2 mEq/L (normal range: 3.5-5.5); Chloride: 105 mEq/L (normal range: 95-105); Creatinine: 0.15 mEq/L (normal range: 0.1-0.6); Prothrombin Time: 13.5 seconds (normal range: 10.1-15.9); Pratial Thromboplastine Time: 31.3 seconds (normal range: 31.3-54). On 21 March 2008, the subject showed data of intestinal obstruction again. On 21 March 2008, second surgery was done; perforation in terminal ileum with necrosis at 10cm of ileocecal valve, abundant reaction peritoneal liquid, micro abscess loop to loop and hepatorenal space were found. Resection of terminal portion of ileon and proximal of medium portion of transverse colon, as well as ileostomy and colostomy were done in the second surgery. After that the evolution was favorable with no evidence of complications. On 03 April 2008, laboratory tests were performed and showed the following: Hemoglobin: 10.8 g/dL (normal range: 10.0-13.0); leucocytes: 14540/mm3 (normal range: 6000-17500); Neutrophils: 60% (normal range: 13-33); Platelets count: 504000/mm3 (normal range: 300000-700000). Finally, the subject was discharged with frank recuperation on 03 April 2008 with date of oleocolography for more functional evolution. Multiple brides were found too, loop to loop was resolved by lysis. The convulsions were observed only before the first surgery, after that they were negative. No evidence of neurological complication. The subject was treated with phenytoin, amikacin (Amikacine), metronidazole, diazepam, midazolam, vecuronium bromide (Vecuronium), ceftazidime sodium (Ceftazidime), vancomycin, fluconazole, nystatin (Nistatin). The physician considered the events were disabling and life threatening. On 3 April 2008, the events were resolved with sequelae. The physician considered the events were possibly related to vaccination with ROTARIX.


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