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This is VAERS ID 335532

Case Details

VAERS ID: 335532 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Female  
Location: Foreign  
Vaccinated:2008-10-20
Onset:2008-11-03
   Days after vaccination:14
Submitted: 2008-12-17
   Days after onset:44
Entered: 2008-12-17
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 mass, Abdominal pain, Appendicectomy, Blood albumin decreased, Blood calcium decreased, Diarrhoea, Food intolerance, Gastrointestinal sounds abnormal, Haematochezia, Haemoglobin normal, Intussusception, Protein total decreased, Rectal haemorrhage, Surgery, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Chronic kidney disease (broad), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad)

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, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Albumin, 04Nov2008, 1.9g/dL; Calcium, 04Nov2008, 8mg/dL; Hemoglobin, 04Nov2008, 10.4g/dL; Hemoglobin, 08Nov2008, 11.5g/dL; Protein total, 04Nov2008, 3.9g/dL
CDC Split Type: B0550031A

Write-up: This case was reported by a physician in the frame of a PASS study and described the occurrence of intussusception in a 5-month-old female subject who was vaccinated with ROTARIX, (GlaxoSmithKline). The subject had no relevant medical history or allergy. Previous and/or concurrent vaccination included ROTARIX (GlaxoSmithKline, oral) given on 13 August 2008, combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (manufacturer unspecified; intramuscular) given on 20 October 2008; pneumococcal vaccines (manufacturer unspecified; intramuscular) given on 20 October 2008. On 20 October 2008, the subject received 2nd dose of ROTARIX (oral, lot number not provided). On 3 November 2008, 14 days after vaccination with 2nd dose ROTARIX, the subject experienced liquid stools, bloody stools, abdominal pain, intolerance to oral feeding and gastrobialry vomiting. On 4 November 2008, the subject was hospitalised. Physical exam reported abdominal mass in mesogastrium, decreased bowel sounds and rectal blood. Lab tests were performed and showed the following: Hemoglobin: 10.4 g/dL; Albumin: 1.9 g/dL; Total protein: 3.9 g/dL; Calcium: 8 mg/dL. Diagnosis of intussusception was made by clinical features. On 04 November 2008, surgery was performed; Ileocecolic intussusception was found and resolved by taxis. Prophylactic appendectomy was done without complications. On 8 November 2008, lab tests was performed and showed the following: Hemoglobin: 11.5 g/dL. The subject was treated with KETOROLAC, CEFTRIAXONE, AMIKACIN, METRONIDAZOLE, RANITIDINE, and NALBUPHINE. The subject had good evolution; she was discharged on 9 November 2008 in good clinical conditions. On 11 November 2008, the events were resolved. The physician considered the events were possibly related to vaccination with ROTARIX.


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