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This is VAERS ID 322869

Case Details

VAERS ID: 322869 (history)  
Form: Version 1.0  
Age: 0.6  
Gender: Male  
Location: Foreign  
Vaccinated:2007-10-25
Onset:2008-01-18
   Days after vaccination:85
Submitted: 2008-08-21
   Days after onset:215
Entered: 2008-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR - / UNK UN / IM
HEP: HEP B (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, Appendicectomy, Haematochezia, Inappropriate schedule of drug administration, Intestinal obstruction, Intussusception, 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 (broad), Medication errors (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? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, Jan2008, See text
CDC Split Type: B0533718A

Write-up: This case was reported by a physician and described the occurrence of intussusception of intestine in a 9-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no history or family history of intussusception or bowel abnormalities. He had no congenital intestinal malformation or other gastrointestinal malformation and dysfunction. Previous and/or concurrent vaccination included diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (manufacturer unspecified; intramuscular) given on 25 October 2007 and 18 July 2008; hepatitis B vaccine recombinant (manufacturer unspecified; intramuscular) given on 27 April 2007, 25 October 2007 and 18 July 2008; live attenuated rotavirus vaccine (GlaxoSmithKline; oral) given on 18 July 2007; pneumococcal vaccine, unspecified (manufacturer unspecified; intramuscular) given on 18 July 2007 and 25 October 2007; tuberculosis vaccine (manufacturer unspecified; intradermal) given on 27 April 2007. On 25 October 2007, the subject received the 2nd dose of ROTARIX (oral, lot number not provided). On 18 January 2008, 85 days after vaccination with the 2nd dose of ROTARIX, the subject was admitted into the emergency room due to 1 day of evolution with 5 times vomiting, gastric content, intolerance to PO and blood stools (seems like black currant jelly) without knowing number. Abdominal ultrasound and abdominal CT were not performed. Diagnostic method was abdominal X-ray with finding of air-fluid levels and data of intestinal obstruction and clinically. The physician considered the events were clinically significant (or requiring intervention). Surgery intervention was decided and was performed on 18 January 2008 with finding of ileococecal intussusception, which remitted by taxis (no resection); prophylactic appendectomy was performed without complications. Physician did not have more evolution notes after the intervention or discharge data; therefore no more data could be provided. At the time of reporting the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.


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