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This is VAERS ID 312613

Case Details

VAERS ID: 312613 (history)  
Form: Version 1.0  
Age: 0.5  
Gender: Female  
Location: Foreign  
Vaccinated:2007-09-06
Onset:2007-11-29
   Days after vaccination:84
Submitted: 2008-05-19
   Days after onset:171
Entered: 2008-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Appendicectomy, Appendicitis, Dehydration, Gastrointestinal sounds abnormal, Haematochezia, Haemoglobin increased, Intussusception, Irritability, Lymphocyte count decreased, Mucous stools, Oral intake reduced, Pharyngeal erythema, Surgery, Vomiting, White blood cell count increased, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (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? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray 29Nov2007 intussusc.unit; HCV 03Dec2007 26.7pg; Hematocrit 03Dec2007 33.8%; Hemoglobin 03Dec2007 99.2g/dL; Lymphocytes 03Dec2007 23.7%; MCV 03Dec2007 80.3FL; Neutrophils 03Dec2007 67.7%; White blood cells 03Dec2007 12700mm3
CDC Split Type: B0520384A

Write-up: This case was reported by a physician in the frame of a PASS study and described the occurrence of intussusception in a 8-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was on no other medication and had no relevant medical history nor allergy. Previous vaccination included ROTARIX (GlaxoSmithKline, oral) given on 4 May 2007. On 6 September 2007 the subject received 2nd dose of ROTARIX (9 ml, oral, lot number not provided). On 29 November 2007, 84 days after vaccination with ROTARIX, the subject experienced vomiting, irritability, abdominal pain, oral intolerance and bloody mucus in stool. She was admitted in the emergency room the same day. Physical exam showed dehydration, hyperaemic pharynx and intestinal silent. An abdominal X-ray was performed showing invagination. she was hospitalised for 5 days. A surgery was performed on 29 November 2007, ileocecal position and appendicitis were found and resolved by taxis and appendectomy. No complication occurred. The subject showed a good clinical evolution, she was treated with cefotaxime and amikacin (Amikacine) and was discharged on 03 December 2007, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.


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