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This is VAERS ID 322079

Case Details

VAERS ID: 322079 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Foreign  
Vaccinated:2007-12-07
Onset:2007-12-22
   Days after vaccination:15
Submitted: 2008-08-13
   Days after onset:234
Entered: 2008-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Apnoea, Dehydration, Gastrointestinal necrosis, Haematochezia, Intussusception, Oral intake reduced, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

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 22DEC2007 showed air fluid levels and dilated bowel loops
CDC Split Type: B0532385A

Write-up: This case was reported by a physician and described the occurrence of intussusception of intestine in a 2-month-old male subject who was vaccinated with ROTARIX, GlaxoSmithKline. Previous and/or concurrent vaccination included combined DTAP, IPOL and HIB; manufacturer unspecified; intramuscular given on 17 December 2007; RECOMBIVAX HB; manufacturer unspecified; intramuscular given on 13 October 2007 and 17 December 2007; PREVNAR, unspecified; manufacturer unspecified; intramuscular given on 17 December 2007; tuberculosis vaccine; non-GSK manufacturer; intradermal given on 13 October 2007. On 7 December 2007 the subject received 1st dose of ROTARIX (oral). On 22 December 2007, 15 days after vaccination with ROTARIX, the subject was brought to the emergency room due to 2 days of evolution with abundant vomiting, intolerance to oral intake, non assess fever and bloody stools (like black currant jelly). The subject was admitted with severe dehydration. Relevant test included abdominal x-ray which showed air fluid levels and dilated loops. The same day the subject underwent a surgery in which ileocecal intussusception was confirmed. In the last portion of the ileo and before the cecal and first portion of colon 5 cm of necrosis was found. A resection was performed in the last portion of ileum, cecal and xyphoid, performed a terminal union without complication. On 01 January 2008 the subject presented apnea and he was intubated for a few hours. Two days after the subject presented a favorable evolution. On 05 January 2008 the subject was discharged. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). On 6 January 2008, the events were resolved. The physician considered the events were possibly related to vaccination with ROTARIX. On 18 February 2008 the subject received the 2nd dose of ROTARIX. No adverse event has been reported.


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