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This is VAERS ID 311730

(NOTE: This result is from the 4/14/2017 version of the VAERS database)

Case Details

VAERS ID: 311730 (history)  
Form: Version .0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2008-03-18
Onset:2008-04-05
   Days after vaccination:18
Submitted: 2008-05-06
   Days after onset:31
Entered: 2008-05-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 - / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal mass, Appendicitis, Convulsion, Dehydration, Gastrointestinal necrosis, Haematochezia, Hyperaemia, Intestinal resection, Intussusception, Irritability, Peristalsis visible, Pharyngotonsillitis, Purulent discharge, Pyrexia, Rectal haemorrhage, Rhinorrhoea, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Agranulocytosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Oropharyngeal infections (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (narrow), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Apr2008 Abdominal X-ray was performed and showed bad distribution of air and distal absence. Plain abdominal radiograph showed fluid levels, dilated bowel loops and non-specific abnormalities. Plain abdominal radiograph did not show a visible intussusception or soft tissue mass.
CDC Split Type: B0517774A

Write-up: This case was reported by a physician and described the occurrence of invagination of intestine in a 4-month-old female subject who was vaccinated with Rotarix (GlaxoSmithKline). The subject had no family history of intussusception or bowel abnormalities. The subject had no history of the following: previous intra-abdominal surgery, congenital intestinal malformation, intestinal polyps, Meckels diverticulum, intestinal vascular malformations, cystic fibrosis, Hirschsprung disease, other gastrointestinal malformation and dysfunction or intussusception. Previous and/or concurrent vaccination included DTap-IPV-HIB (manufacturer unspecified; intramuscular; unknown) given on 15 February 2008; Hep B (manufacturer unspecified; intramuscular; unknown) given on 15 November 2007 and 15 January 2008; pneumococcal vaccine, unspecified (manufacturer unspecified; intramuscular; unknown) given on 15 February 2008; tuberculosis vaccine (GlaxoSmithKline; intradermal; unknown) given on 15 November 2007. On 18 March 2008 and 15 January 2008, the subject received the 2nd dose and the 1st dose of Rotarix (oral). On unspecified date (one week before admission), at an unspecified time after vaccination with Rotarix, the subject started with hyaline rhinorrhea and fever with good response after receiving non specific treatment. However on 05 April 2008 she presented generalized seizures, reason why she was admitted to hospital, at the same time she started with bloody stools. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). Physical examination reported dehydration, irritability, pharyngotonsillitis with hyperemia, purulent exudates without no respiratory difficulty or meningeal irritation, non-tender abdomen, normal peristalsis, only rectal bleeding was observed and gastrobiliary vomiting. On left abdomen a pain-palpable mass (Morcilla and Dance signs) was found. Abdominal X-ray was performed and showed bad distribution of air and distal absence. Plain abdominal radiograph showed fluid levels, dilated bowel loops and non-specific abnormalities. Plain abdominal radiograph did not show a visible intussusception or soft tissue mass. The subject required intervention on 06 April 2008 suspecting intestinal invagination and corroborating that it was ileocecal IS with complications appendiceal necrosis, cecal, ascendant colon and 5 cm of ileum. A resection of necrotic structures was performed without complications. The subject had good clinical response, with no infections or seizures. Neuro infection was discarded. The subject had good response to PO, normal evacuations and he was finally discharged on 12 April 2008 in good clinical conditions. On 12 April 2008, the events were resolved. The physician considered the events were unrelated to vaccination with Rotarix.


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