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This is VAERS ID 322638

Case Details

VAERS ID: 322638 (history)  
Form: Version 1.0  
Age: 0.1  
Gender: Female  
Location: Foreign  
Vaccinated:2007-12-12
Onset:2008-04-03
   Days after vaccination:113
Submitted: 2008-08-19
   Days after onset:138
Entered: 2008-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Appendicectomy, Gastric disorder, Haematochezia, Inappropriate schedule of drug administration, Intussusception, Surgery, Vomiting
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 (broad), Medication errors (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? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0533447A

Write-up: This case was reported by a physician and described the occurrence of ileo-ceco-colic intussusception in a 5-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history. Previous and/or concurrent vaccination included DTPa-IPV-HIB (manufacturer unspecified, intramuscular) given on 12 December 2007, 15 February 2008 and 15 April 2008; pneumococcal vaccine, unspecified (manufacturer unspecified, intramuscular) given on 12 December 2007 and 15 February 2008; tuberculosis vaccine (manufacturer unspecified, intradermal) given on 25 October 2007. On 12 December 2007, the subject received 1st dose of ROTARIX (oral). Lot number not provided. On 3 April 2008, 113 days after vaccination with ROTARIX, the subject was taken to ER with gastric intolerance with 5 episodes of vomiting and 2 bloody stools like black currant jelly. The diagnosis was done clinically. Surgery was performed on 3 April 2008 and showed ileo-ceco-colic intussusception resolved by taxis with prophylactic appendectomy without resection and complication. The patient had good response and was discharged on 6 April 2008. No abdominal x-ray, ultrasound or scan was performed. The physician considered the events were clinically significant (or requiring intervention). On 6 April 2008, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.


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