Investigational new drug
Item
[A] Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period.
boolean
C0013230 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
Concomitant Medication
Item
[ B ] Chronic administration (defined as more than 14 days) of immunosuppressants or other immunemodifying 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])
C1533734 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0005525 (UMLS CUI [2,1])
C1533734 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
Meningococcal Vaccine
Item
[ C ] Administration of a meningococcal vaccine not planned by the protocol during the whole study period.
boolean
C0700144 (UMLS CUI [1,1])
C1444655 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Other Vaccines
Item
[ D ] Administration of a vaccine not foreseen by the study protocol during the period starting from one month before each dose of vaccine(s) and ending 30 days after, with the exception of OPV.
boolean
C0042210 (UMLS CUI [1,1])
C1444655 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Immunoglobulins | Blood products
Item
[ E ] Administration of immunoglobulins and/or any blood products during the study period.
boolean
C0021027 (UMLS CUI [1,1])
C0371802 (UMLS CUI [1,2])
Anaphylactic reaction
Item
[ A ] Anaphylactic reaction following the administration of vaccine(s).
boolean
C0002792 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Acute severe illness
Item
[ B ] Acute disease at the time of enrolment. (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. Axillary temperature <37.5°C / Rectal temperature <38°C
boolean
C4061114 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Fever
Item
[ C ] Axillary temperature x37.5°C / Rectal temperature x38°C.Fe
boolean
C0015967 (UMLS CUI [1])
Hypersensitivity
Item
[ D ] Hypersensitivity reaction due to the vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Central nervous system disorder
Item
[ E ] Encephalopathy defined as an acute, severe central nervous system disorder occurring within seven days following vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persisted more than a few hours, with failure to recover within 24 hours.
boolean
C0007682 (UMLS CUI [1,1])
C1510821 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
High fever
Item
[ F ] Temperature x40.5°C (rectal) or x40.0°C (axillary) within 48 hours following vaccination, not due to another identifiable cause.
boolean
C0015967 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
C1510821 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,4])
Collapse or Shock
Item
[ G ] Collapse or shock-like state (e.g., hypotonic-hyporesponsive episode) within 48 hours following vaccination.
boolean
C0344329 (UMLS CUI [1,1])
C1510821 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0036974 (UMLS CUI [2,1])
C1510821 (UMLS CUI [2,2])
C0042210 (UMLS CUI [2,3])
Persistent Crying
Item
[ H ] Persistent, inconsolable crying lasting xthree hours, occurring within 48 hours following vaccination.
boolean
C2721683 (UMLS CUI [1,1])
C1510821 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])