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This is VAERS ID 314406

Case Details

VAERS ID: 314406 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Foreign  
Vaccinated:2007-10-08
Onset:2008-03-09
   Days after vaccination:153
Submitted: 2008-05-30
   Days after onset:81
Entered: 2008-05-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 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 - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal pain, Appendicectomy, Dehydration, Diarrhoea, Gastrointestinal hypomotility, Haematochezia, Hypovolaemia, Intensive care, Intussusception, Irritability, Surgery, Vomiting, Wheezing, X-ray abnormal
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad), Dehydration (narrow)

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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 11Mar2005, see textunit
CDC Split Type: B0522122A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 7-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included DTaP-IPV-HIB (manufacturer unspecified, intramuscular) given on 8 October 2007 and 13 February 2008; hepatitis B vaccine recombinant (manufacturer unspecified, intramuscular) given on 8 October 2007 and 13 February 2008; influenza virus vaccine (manufacturer unspecified, intramuscular) given on 7 August 2007 and 7 February 2008; pneumococcal vaccine, unspecified (manufacturer unspecified, intramuscular) given on 6 November 2007; tuberculosis vaccine (manufacturer unspecified, intradermal) given on 7 August 2007. On 8 October 2007 the subject received 1st dose of ROTARIX (oral). On 9 March 2008, 5 months after vaccination with ROTARIX, the subject experienced irritability, gastric vomiting, 9 x), fetid liquid stools. On 10 March 2008, the subject presented bloody stools, abdominal distension and continued vomiting. The subject went to the emergency room presenting dehydration, irritability, a few wheezing, decreased peristalsis and abdominal pain without palpable mass. Relevant test performed on 11 March 2008 included abdominal x-ray with air fluid levels which showed very dilated intestinal loops. The same day the subject underwent a surgery where it was found ileocecal intussusception and it was reduced by taxis. The subject also had an appendectomy. During surgery the subject had hypovolemia and he was sent to pediatric intensive care unit for hemodinamic monitoring. He presented ileo reflux improvement for 36 hours. The physician considered the events were clinically significant (or requiring intervention). The subject was treated with AMPICILLIN, pain medication and gastric protection. On 18 March 2008, the subject was discharged in good clinical conditions. The physician considered the events were unrelated to vaccination with ROTARIX.


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