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This is VAERS ID 326447

Case Details

VAERS ID: 326447 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Female  
Location: Foreign  
Vaccinated:2008-07-17
Onset:2008-08-01
   Days after vaccination:15
Submitted: 2008-09-29
   Days after onset:59
Entered: 2008-09-29
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
PPV: PNEUMO (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, Abdominal pain, Faeces discoloured, Haematochezia, Intestinal obstruction, Intussusception, Surgery, Vomiting, X-ray abnormal
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), Noninfectious diarrhoea (broad)

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, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 02Aug2008, ISUnit
CDC Split Type: B0538598A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 5-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included DTaP-IPV-HIB; manufacturer unspecified; intramuscular given on 8 May 2008 and 17 July 2008; Hep B; manufacturer unspecified; intramuscular given on 3 April 2008, 8 May 2008 and 17 July 2008; ROTARIX; GlaxoSmithKline; oral given on 8 May 2008; pneumococcal vaccine, unspecified; manufacturer unspecified; intramuscular given on 8 May 2008 and 17 July 2008; tuberculosis vaccine; manufacturer unspecified; intradermal given on 3 April 2008. On 17 July 2008 the subject received 2nd dose of ROTARIX (oral) lot number not provided. On 1 August 2008, 15 days after vaccination with ROTARIX, the subject experienced abdominal pain, bloody stools (like black current jelly) and continuing vomiting, clinically with data of intestinal intussusception. On 02 August 2008 relevant test included abdominal x-ray showing data of intestinal obstruction. The plain abdominal radiograph showed dilated bowel loops and non-specific abnormalities. The same day the subject underwent a surgery confirming ileoileocolic invagination which was resolved by taxis without complications. No bowel resection was needed. After surgery the subject had a good response. On 07 August 2008 the subject was discharged. The subject was hospitalized and the physician considered the events were life threatening and clinically significant (or requiring intervention). The physician considered the events were possibly related to vaccination with ROTARIX.


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