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This is VAERS ID 317778

Case Details

VAERS ID: 317778 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Male  
Location: Foreign  
Vaccinated:2008-04-14
Onset:2008-06-02
   Days after vaccination:49
Submitted: 2008-06-27
   Days after onset:25
Entered: 2008-06-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal tenderness, Acidosis, Appendicectomy, Convulsion, Dehydration, Diarrhoea, Gastrointestinal sounds abnormal, Haematochezia, Hypovolaemic shock, Intussusception, Mucous stools, Pain, Pyrexia, Surgery, Vomiting
SMQs:, Acute pancreatitis (broad), Lactic acidosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Hypovolaemic shock conditions (narrow), Convulsions (narrow), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (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), Generalised convulsive seizures following immunisation (narrow), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
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, 05Jun2008, see textunit
CDC Split Type: B0526485A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous vaccination included ROTARIX (GlaxoSmithKline); oral given on 5 February 2008. On 14 April 2008 the subject received 2nd dose of ROTARIX (oral). On 2 June 2008, 49 days after vaccination with ROTARIX, the subject experienced high fever (not quantified), loose stools with mucous and blood, and vomiting (unknown number of episodes). Therefore he was treated as outpatient without improvement. On 05 June 2008 the subject presented 3 episodes of generalise seizure, therefore he was hospitalised. Physical examination included bad general conditions, severe dehydration, clinical data of hypovolemic shock with acidosis, abdominal distention, painful at median and deep pressure, peritoneal reaction and abolished peristalsis. Abdominal x-ray showed distended loops and intestinal obstruction. The subject was rehydrated with plan "C" from an organization. The same day the subject underwent a surgery in which intussusception was confirmed. An appendectomy was also done. After surgery the subject evolved to clinical improvement. On 10 June 2008 the subject was discharged in good clinical conditions. Seizure was considered as secondary to fever. No specific studies were done. The subject was hospitalised for 6 days and the physician considered the events were life threatening. The subject was treated with metoclopramide, metronadizole, paracetamol, ampicillin, metamizole, diazepam, amikacin, midazolam, rehydration and surgery.


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