Pharmaceutical Preparations, Vaccination
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period.
boolean
C0013227 (UMLS CUI [1])
C0042196 (UMLS CUI [2])
Immunosuppressive Agents, Chronic
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune- modifying drugs during the study period. (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Vaccination, Concomitant Agent
Item
Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine(s) and ending 30 days after.
boolean
C0042196 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Hib-MenCY-TT vaccine; Meningococcal Vaccine
Item
Administration of a Hib or a meningococcal vaccine not foreseen by the study protocol since birth and for a period up to one month after the booster vaccine dose.
boolean
C2352428 (UMLS CUI [1])
C0700144 (UMLS CUI [2])
Neisseria meningitidis, Intercurrent disease; Haemophilus influencae type b, Intercurrent disease
Item
Intercurrent Neisseria meningitidis disease and intercurrent Haemophilus influenzae type b disease.
boolean
C0027575 (UMLS CUI [1,1])
C0277557 (UMLS CUI [1,2])
C0121772 (UMLS CUI [2,1])
C0277557 (UMLS CUI [2,2])
Immunoglobulins, Blood Product
Item
Administration of immunoglobulins and/or any blood products during the study period.
boolean
C0021027 (UMLS CUI [1,1])
C0456388 (UMLS CUI [1,2])
Immunologic Deficiency Syndromes
Item
Any confirmed or suspected immunosuppressive or imunodeficient condition based on medical history and physical examination (no laboratory testing is required)
boolean
C0201388 (UMLS CUI [1])
Vaccination, Hypersensitivity
Item
Anaphylactic reaction following the administration of vaccine.
boolean
C0042196 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
Vaccination, Hypersensitivity
Item
Hypersensitivity reaction to the vaccine.
boolean
C0042196 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
Encephalopathies, Administration of vaccines, Post
Item
Encephalopathy (not due to another identifiable cause). This is defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination, and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist more than a few hours, with failure to recover within 24 hours. Even though causation by DTPa vaccine cannot be established, no subsequent doses of pertussis vaccine should be given.
boolean
C0085584 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
Nervous system disorder, Progressive disease
Item
Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy. Pertussis vaccine should not be administered to individuals with such conditions until a treatment regimen has been established and the condition has stabilized.
boolean
C0027765 (UMLS CUI [1,1])
C1335499 (UMLS CUI [1,2])
Body Temperature, Administration of vaccine, Post
Item
Fever ≥ 40.5°C (rectal temperature) within 48 hours of vaccination not due to another identifiable cause.
boolean
C0005903 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
Collapse, Administration of vaccine, Post
Item
Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination.
boolean
C0344329 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
Persistent Crying, Administration of vaccine, Post
Item
Persistent, inconsolable crying lasting ≥3 hours, occurring within 48 hours of vaccination.
boolean
C2721683 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
Seizures, Administration of vaccine, Post
Item
Seizures with or without fever occurring within 3 days of vaccination.
boolean
C0036572 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
Vaccines, Component, Hypersensitivity
Item
History of hypersensitivity to any component of the vaccine, including diphtheria toxoid.
boolean
C0042210 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,3])
Vaccines, Component, Hypersensitivity
Item
Hypersensitivity to any component of the vaccine including diphtheria toxoid. As with other vaccines, the administration of Meningitec® should be postponed in subjects suffering from acute febrile illness.
boolean
C0042210 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,3])
Latex allergy
Item
History of allergic disease or reactions to latex.
boolean
C0577628 (UMLS CUI [1])
Vaccines, Component, Hypersensitivity
Item
History of hypersensitivity to any component of the vaccine, including tetanus toxoid.
boolean
C0042210 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,3])
Acute disease, During, Administration of vaccine
Item
Acute disease at the time of vaccination. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. rectal temperature <38°C, axillary temperature <37.5°C).
boolean
C0001314 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,3])
Fever
Item
Fever at the time of vaccination - Rectal temperature ≥38°C, axillary ≥37.5°C.
boolean
C0015967 (UMLS CUI [1])