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This is VAERS ID 335903

Case Details

VAERS ID: 335903 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2008-05-29
Onset:2008-12-03
   Days after vaccination:188
Submitted: 2008-12-22
   Days after onset:19
Entered: 2008-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal mass, Abdominal wall haematoma, Appendicectomy, Appendix disorder, Blood creatinine normal, Blood fibrinogen increased, Blood glucose normal, Diarrhoea, Gastrointestinal sounds abnormal, Haematochezia, Haematocrit normal, Haemoglobin normal, Ileus, International normalised ratio decreased, Intestinal dilatation, Intussusception, Lymphadenitis, Pain, Pallor, Platelet count normal, Prothrombin level normal, Pyrexia, Specific gravity urine, Thrombosis, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms 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, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 05Dec2008, see text; Abdominal X-ray, 07Dec2008, see text; Blood glucose, 05Dec2008, 82mg/dL; Creatinine, 05Dec2008, 0.4 mg/dL; Fibrinogen, 05Dec2008, 405g/L; Hematocrit, 05Dec2008, 34.8%; Hemoglobin, 05Dec2008, 11.9g/dL; International normalized ratio, 05Dec2008, 0.95; Platelet count, 05Dec2008, 359000/mm3; Prothrombin time, 05Dec2008, 11.2 Sec; Urine specific gravity, 05Dec2008, 1.010
CDC Split Type: B0551171A

Write-up: This case was reported by a physician in the frame of pass study and described the occurrence of intussusception in an 8-month-old male subject who was vaccinated with ROTARIX. The subject had no relevant medical history or allergy. Previous vaccination included ROTAVIRUS vaccine (oral) given on 29 march 2008. On 29 March 2008, the subject received a 2nd dose of ROTARIX (oral, lot number not provided). On 3 December 2008, 6 months after vaccination with 2nd dose of ROTARIX, the subject experienced gastroalimentary vomiting, liquid and bloody stools. The subject received ambulatory treatment with AMPICILLIN trihydrate (AMPICILLIN) and PARACETAMOL (acetaminophen) secondary to rhinopharyngeal infection without improvement. On 5 December 2008, the subject was hospitalised. Physical exam reported pallor, abdominal distention with mass in descendent colon and rectal tact with abundant blood and open sphincter. Lab test were performed and showed the following Glucose: 92mg/dL; Creatinine: 0.4mg/dL; Urine specific gravity: 1.010; Hemoglobin:11.9 g/dL; Hematocrit: 34.8%; Platelets count: 35900/mm3; Prothrombin time:11.2 seconds; International normalized ratio: 0.95; Fibrinogen: 405 g/dL. Abdominal X- ray was performed and showed only loops dilatation. Diagnosis of intussusception was made. Surgery was performed on 5 December 2008. Intussusception Ileocolic and congested appendix was found and resolved by taxis, appendectomy was done with adentis mesenteric findings. The subject had bad evolution, he presented intestinal occlusion with abdominal distention, pain to palpitation, decreased bowel sounds, gasrobilary vomiting and fever. On 7 December 2008, abdominal X-ray was performed and showed ileon loops dilatation and paralytic ileus. On 9 December 2008, surgery was performed again, wall hematoma, thrombosis in 6 cm length mesentery, congestion and dilatation in sigmoid and descendent colon were found. it was resolved by anterograde decompressor colonic and aspiration of coagula with good evolution. The subject was treated with AMIKACIN, RANITIDINE, METRONIDAZOLE; METOCLOPRAMIDE(METOCLOPRAMID); FRUSEMIDE (FUROSEMIDE) , CEFOTAXIME and KETOROLAC TROMETAROL ( KETOROLAC). On 16 December 2008, the subject was discharged. On 16 December 2008, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.


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