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This is VAERS ID 322639

Case Details

VAERS ID: 322639 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:2008-02-05
Onset:2008-04-01
   Days after vaccination:56
Submitted: 2008-08-19
   Days after onset:140
Entered: 2008-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Appendicectomy, Gastrointestinal necrosis, Haematochezia, Intestinal anastomosis, Intestinal obstruction, Intussusception, Oral intake reduced, Surgery, Vomiting, X-ray abnormal
SMQs:, 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)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 03Apr2008, abnormal
CDC Split Type: B0533443A

Write-up: This case was reported by a physician and described the occurrence of intussusception of intestine in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included DTPa-IPV-HIB; manufacturer unspecified; intramuscular given on 25 February 2008; hepatitis B vaccine recombinant; manufacturer unspecified; intramuscular given on 8 December 2007 and 25 February 2008; pneumococcal vaccine, unspecified (manufacturer unspecified; intramuscular given on 25 February 2008; tuberculosis vaccine; non-GSK manufacturer; intradermal given on 3 December 2007. On 5 February 2008 the subject received 1st dose of ROTARIX (oral). On 03 April 2008, 2 months after vaccination with ROTARIX, the subject was in the emergency room due to 1 day of evolution of gastric vomiting (8 times), intolerance to oral intake and 2 bloody stools (seemed like black current jelly stools). Relevant test include abdominal x-ray finding air-fluid levels and data of intestinal obstruction. The same day the subject underwent a surgery in which it was found ileococecal intussusception with necrosis ileum (8 cm) and ascending colon (15 cm). A prophylactic appendectomy was also done and termini terminal union without complications. On 10 April 2008, 7 days after the subject presented a good evolution, therefore he was discharged. The subject was treated with cefotaxime, amikacin and metronidazole. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). On 10 April 2008, the events were resolved. The physician considered the events were possibly related to vaccination with ROTARIX. On 25 April 2008 the subject was revaccinated with the 2nd dose of ROTARIX (oral), 2nd dose of DTPa-IPV-HIB; manufacturer unspecified; intramuscular and 2nd dose of pneumococcal vaccine, unspecified; manufacturer unspecified.


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