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This is VAERS ID 312607

Case Details

VAERS ID: 312607 (history)  
Form: Version 1.0  
Age: 0.5  
Gender: Female  
Location: Foreign  
Vaccinated:2008-02-05
Onset:2008-03-12
   Days after vaccination:36
Submitted: 2008-05-19
   Days after onset:68
Entered: 2008-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Blood creatinine increased, Blood potassium decreased, Blood sodium normal, Dehydration, Diarrhoea, Grand mal convulsion, Haematochezia, Haematocrit normal, Haemoglobin decreased, Intussusception, Malaise, Nervous system disorder, Neutrophil percentage increased, Pallor, Platelet count normal, Stool analysis normal, Vomiting, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Hemoglobin: 10.9 g/dL (normal range: 10.0-13.0); Hematocrit: 32.7 % (normal range: 29-42); Platelets count: 489000/mm3 (normal range: 300000-700000); Neutrophils: 75.5% (normal range: 13-33); Sodium 143 mEq/L (normal range: 135-145); Potassium: 4.3 mEq/L (normal range: 3.7-5.5). On 15 March 2008, laboratory tests were performed and showed the following: Hemoglobin: 6 g/dL (normal range: 10.0-13.0); Potassium: 2.1 mEq/L (normal range: 3.5-5.5). On 19 March 2008, laboratory tests were performed and showed the following: Sodium: 141 mEq/L (normal range: 135-145); Potassium: 5.2 mEq/L (normal range: 3.5-5.5); Chloride: 105 mEq/L (normal range: 95-105); Creatinine: 0.15 mEq/L (normal range: 0.1-0.6); Prothrombin Time: 13.5 seconds (normal range: 10.1-15.9); Pratial Thromboplastine Time: 31.3 seconds (normal range: 31.3-54). On 03 April 2008, laboratory tests were performed and showed the following: Hemoglobin: 10.8 g/dL (normal range: 10.0-13.0); leucocytes: 14540/mm3 (normal range: 6000-17500); Neutrophils: 60% (normal range: 13-33); Platelets count: 504000/mm3 (normal range: 300000-700000).
CDC Split Type: B0520189A

Write-up: This case was reported by a physician in the frame of a PASS study and described the occurrence of intussusception in a 7-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previously, the subject was healthy. Previous vaccination included ROTARIX (GlaxoSmithKline; oral) given on 6 December 2007. On 5 February 2008, the subject received the 2nd dose of ROTARIX (oral). On 12 March 2008, 36 days after vaccination with the 2nd dose of ROTARIX, the subject experienced oral intolerance, gastroalimentary vomiting, then biliar and one liquid stool. The subject was hospitalised on ER (date of hospitalisation was not available in the chart). The subject showed 11 "mucosanguinolent" stools, malaise, pallor, abdominal distension, dehydration and most severe conditions. Laboratory tests were performed and showed the following: Hemoglobin: 10.9 g/dL (normal range: 10.0-13.0); Hematocrit: 32.7 % (normal range: 29-42); Platelets count: 489000/mm3 (normal range: 300000-700000); Neutrophils: 75.5% (normal range: 13-33); Sodium 143 mEq/L (normal range: 135-145); Potassium: 4.3 mEq/L (normal range: 3.7-5.5). Entamoeba histolytica test (fresh stool) was performed and was negative. The subject was sent to another hospital with surgical pediatric attention. On 15 March 2008, at physical exam, the subject showed severe dehydration, pallor, malaise, tonic-clonic generalized convulsions, neurological deterioration, abdominal zone with distension, pain, without palpable mass, expulsion of current jelly stool and delayed capillary filling. No abdominal x-ray was reported in the clinical file. On 15 March 2008, laboratory tests were performed and showed the following: Hemoglobin: 6 g/dL (normal range: 10.0-13.0); Potassium: 2.1 mEq/L (normal range: 3.5-5.5). On 15 March 2008, the subject received the first transfusion of globular package (86ml) without complication. On 15 March 2008, surgery was performed; intussusception ileo-ceco-colic was found with large invagination up to descendent colon with ischemic intestinal . Ten minutes after, the subject showed recuperation. For this reason resection was not done. On 15 March 2008, after surgery, the subject received transfusion of globular package (160 ml). The subject received also frozen plasma (90ml) without complication. On 19 March 2008, laboratory tests were performed and showed the following: Sodium: 141 mEq/L (normal range: 135-145); Potassium: 5.2 mEq/L (normal range: 3.5-5.5); Chloride: 105 mEq/L (normal range: 95-105); Creatinine: 0.15 mEq/L (normal range: 0.1-0.6); Prothrombin Time: 13.5 seconds (normal range: 10.1-15.9); Pratial Thromboplastine Time: 31.3 seconds (normal range: 31.3-54). On 21 March 2008, the subject showed data of intestinal obstruction again. On 21 March 2008, second surgery was done; perforation in terminal ileum with necrosis at 10cm of ileocecal valve, abundant reaction peritoneal liquid, micro abscess loop to loop and hepatorenal space were found. Resection of terminal portion of ileon and proximal of medium portion of transverse colon, as well as ileostomy and colostomy were done in the second surgery. After that the evolution was favorable with no evidence of complications. On 03 April 2008, laboratory tests were performed and showed the following: Hemoglobin: 10.8 g/dL (normal range: 10.0-13.0); leucocytes: 14540/mm3 (normal range: 6000-17500); Neutrophils: 60% (normal range: 13-33); Platelets count: 504000/mm3 (normal range: 300000-700000). Finally, the subject was discharged with frank recuperation on 03 April 2008 with date of oleocolography for more functional evolution. Multiple brides were found too, loop to loop was resolved by lysis. The convulsions were observed only before the first surgery, after that they were negative. No evidence of neurological complication. The subject was treated with phenytoin, amikacin (Amikacine), metronidazole, diazepam, midazolam, vecuronium bromide (Vecuronium), ceftazidime sodium (Ceftazidime), vancomycin, fluconazole, nystatin (Nistatin). The physician considered the events were disabling and life threatening. On 3 April 2008, the events were resolved with sequelae. The physician considered the events were possibly related to vaccination with ROTARIX.


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