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This is VAERS ID 312640

(NOTE: This result is from the 5/13/2013 version of the VAERS database)

Case Details

VAERS ID: 312640 (history)  
Form: Version .0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-03-27
Onset:2008-04-01
   Days after vaccination:5
Submitted: 2008-05-20
   Days after onset:49
Entered: 2008-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / - - / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal pain, Abdominal rigidity, Crying, Enema administration, Feeding disorder of infancy or early childhood, Haematochezia, Hyperhidrosis, Intussusception, Irritability, Pallor, Screaming, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 02Apr2008, See text
CDC Split Type: B0520012A

Write-up: This case was reported by a regulatory authority ((clinical) # 016761344) and described the occurrence of intussusception in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 27 March 2008, the subject received unspecified dose of ROTARIX (oral, lot number not provided). On 1 April 2008, 5 days after vaccination with ROTARIX, the subject experienced intussusception. The patient showed crying and screaming in intermittent episodes, pallor and sweating. The abdomen was hard and painful to palpation in right hemi-abdomen. He also showed vomiting, irritability with delay in his feedings and bloody stools. For these reasons he was taken to the Emergency room. The subject was hospitalised. On 2 April 2008, abdominal X-ray was performed and showed compatible findings with intestinal intussusception. Opaque enema was performed: Ileo-ceco-colic intussusception was reduced by hydrostatic pressure, with good oral tolerance 20 hours later. On 3 April 2008, the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with ROTARIX. No further information is expected as this is the only information the Regulatory Authority has, therefore this case has been considered closed.


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