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This is VAERS ID 322073

Case Details

VAERS ID: 322073 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-03-07
Onset:2008-03-13
   Days after vaccination:6
Submitted: 2008-08-13
   Days after onset:153
Entered: 2008-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
HEP: HEP B (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
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Appendicectomy, Barium double contrast, Conjunctivitis, Enema administration, Familial risk factor, Haematochezia, Intussusception, Irritability, Pyrexia, Rhinorrhoea, Surgery, X-ray abnormal
SMQs:, Severe cutaneous adverse reactions (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Ischaemic colitis (broad), Conjunctival disorders (narrow), Ocular infections (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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: Abdominal X-ray, 13Mar2008, abnormal
CDC Split Type: B0532220A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had genetic antecedents of cardiopathy. Previous and/or concurrent vaccination included DTaP-IPV-HIB (manufacturer unspecified, intramuscular) given on 7 March 2008; Hep B (manufacturer unspecified, intramuscular) given on 19 December 2007 and 7 March 2008; pneumococcal vaccine (manufacturer unspecified, intramuscular) given on 7 March 2008; tuberculosis vaccine (manufacturer unspecified, intradermal) given on 19 December 2007. On 7 March 2008, the subject received 1st dose of ROTARIX (oral). Lot number not provided. On 13 March 2008, 6 days after vaccination with ROTARIX, the subject was taken to ER with rhinorrhea, conjunctival secretions, fever, irritability and 2 bloody stools like black current jelly. Intussusception was suspected. The patient was hospitalized. On 14 March 2008, ileo-ileo-cecolic intussusception was diagnosed with resolved by taxis with appendectomy without resection and complication. The subject had good response and favorable evolution. The physician considered the events were clinically significant or requiring intervention). Abdominal X-ray was performed and showed fluid levels and dilated bowel loops. Air or Liquid contrast enema did not show visible intussusception or soft tissue mass, or invagination of intestine, or specific abnormalities. On 26 March 2008, the events were resolved by surgery and the patient was discharged. The physician considered the events were possibly related to vaccination with ROTARIX.


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