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This is VAERS ID 309529

Case Details

VAERS ID: 309529 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2007-12-31
Onset:2008-01-19
   Days after vaccination:19
Submitted: 2008-04-15
   Days after onset:86
Entered: 2008-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal pain, Abnormal faeces, Aspiration biopsy, Band neutrophil percentage increased, Barium double contrast, Enema administration, Haematochezia, Hypertrophy, Intussusception, Lymphocyte percentage decreased, Neutrophil percentage increased, Occult blood positive, Peristalsis visible, Platelet count increased, Vomiting, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Biliary system related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 20Jan2008, Abnormalunit; Air contrast barium enema, 20Jan2008, Invaginationunit; Aspiration biopsy, 20Jan2008, Negativeunit; Band neutrophil percentage, 20Jan2008, 6%; Fecal occult blood, 20Jan2008, positiveunit; Lymphocytes, 20Jan2008, 18%; Neutrophils, 20Jan2008, 71%; Platelet count, 20Jan2008, 820000/mm3; White blood cells, 20Jan2008, 23800/mm3
CDC Split Type: B0508483A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 4-month-old male subject who was vaccinated with Rotarix (GlaxoSmithKline). Previous and/or concurrent vaccination included DTaP + IPV + Hib; manufacturer unspecified; intramuscular; given on 30 October 2007 and on 31 December 2007; Hep B; manufacturer unspecified; intramuscular; given on 2 September 2007 and on 30 October 2007; Rotarix; GlaxoSmithKline; oral given on 30 October 2007; tuberculosis vaccine; manufacturer unspecified; intradermal; given on 2 September 2007. On 31 December 2007, the subject received 2nd dose of Rotarix (oral), lot number not provided. On 19 January 2008, 19 days after vaccination with Rotarix, the subject experienced one bloody stool. On 20 January 2008, he experienced 3 times vomiting. The subject was brought to emergency ward. At examination, abdominal pain with normal peristalsis was found. He experienced current jelly stool and intussusception was suspected. The laboratory tests showed white blood cell 23800/mm3, neutrophils 71%, neutrophil band 6%, lymphocytes 18%, platelets 820000/mm3. The fecal occult blood test was positive whereas the fine needle aspiration biopsy was negative. Abdominal X-ray showed air fluid level with distal gas. The diagnosis of intussusception was confirmed by the barium air enema. The subject was hospitalised and the physician considered the events were life threatening and clinically significant (or requiring intervention). On 20 January 2008, surgery was performed and ileocolic intussusception of 20 cm was found as well as Peyer plaques hypertrophy. The intussusception was reduced without complication. No resection was performed. On 23 January 2008, the events were resolved. The subject was discharged from hospital on 25 January 2008 in good clinical condition. The physician considered the events were possibly related to vaccination with Rotarix. Follow-up received on 9 April 2008: The events were resolved on 25 January 2008.


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