V čase vyhlásenia pandémie SZO sa očkuje veľké množstvo ľudí špeciálne pripravenými tzv. pandemickými vakcínami. Z toho dôvodu je potrebné, aby všetci všeobecní lekári pre dospelých, pre deti a dorast, ambulantní špecialisti a lekári na klinikách hlásili každé podozrenie na nežiaducu reakciu vakcíny, predovšetkým tie, patriace do týchto kategórií:
- 1. Závažné neočakávané nežiaduce reakcie
Neočakávaná reakcia je tá, ktorá nie je uvedená v súhrne charakteristických vlastností lieku
- 2. Smrteľné aleboživot ohrozujúce závažné nežiaduce reakcie
Vrátane každej hospitalizácie a predĺženia hospitalizácie v dôsledku nežiaducej reakcie
- 3. Nežiaduce reakcie zvláštneho významu (AESI):
a. Neuritída
b. Kŕče
c. Anafylaxia
d. Encefalitída, myelitída
e. Vaskulitída
f. Syndróm Guillain-Barré
g. Bellova obrna nervu facialis
h. Demyelizujúce ochorenie
i. Zlyhanie vakcinácie
Ich definície sú uvedené v prílohe.
Hlásenie sa zasiela na ŠÚKL a na najbližší Regionálny úrad verejného zdravotníctva Tlačivo hlásenia sú na (klikni sem): Tlačivo hlásenia
Pre správne zhodnotenie hlásenia je potrebné, aby boli uvedené aj tieto údaje:
- a. Údaje opacientovi, vek, pohlavie, tehotenstvo, rizikové faktory
- b. Kedy očkovaný, akou vakcínou, akou šaržou, akou dávkou, po ktorej dávke vporadí sa objavila reakcia.
- c. Nežiaduci účinok, aké kritériá boli použité na diagnózu ochorenia, sú dostupné ďalšie údaje potrebné na diagnózu ochorenia?
- d. Kto očkoval, špecialista, ktorý potvrdil diagnózu, kto hlásil
Pacientom, ktorí majú nežiaducu reakciu sa odporúča, aby navštívili svojho lekára a požiadali ho o vypísanie hlásenia nežiaduceho účinku. Bližšie údaje sú na (klikni sem): Rada pre pacientov - čo robiť v prípade vedľajšieho účinku?
Niektoré definície nežiaducich účinkov
Definície je možné nájsť na týchto adresách:
http://www.brightoncollaboration.org/intranet/en/index/document_download.html
http://www.cioms.ch/Vaccination_failure_Position_paper_final_080429.pdf
http://www.cioms.ch/publications/reporting_adverse_drug.pdf
Vaccination Failure
a) Confirmed Vaccination Failure
The occurrence of the specific vaccine-preventable disease in a person who is appropriately and fully vaccinated taking into account the incubation period and the normal delay for the protection to be acquired as a result of immunization.
This definition requires clinical and laboratory confirmation (or epidemiological link to a confirmed case) that the actual disease is vaccine preventable, i.e. that the pathogen (including, where appropriate, type, subtype, variant, etc.) and clinical manifestations are specifically targeted by the vaccine.
b) Suspected Vaccination Failure
Suspected vaccination failure is defined as the occurrence of disease in an appropriately and fully vaccinated person, but the disease is not confirmed to be the specific vaccine preventable disease, e.g. invasive pneumococcal disease of unknown serotype in a fully vaccinated person.
c) Immunological Failure
Immunological failure is defined as failure of the vaccinee to develop the accepted marker of protective immune response. This definition requires that there is an accepted correlate or marker for protection, and that the vaccinee has been tested/examined at an appropriate time interval after completion of immunization.
Adverse Events of Special Interest (AESI)
AESI Case definition Source
Neuritis. Optic neuritis: DeStefano et al. 2003
unilateral or bilateral visual loss, blurred vision, ophthalmic pain, and diagnosis of ON (confirmed by ophthalmologist) occurring within 6-week risk period after first vaccination
Vestibular neuritis: Baloh 2003
spontaneous, prolonged vertigo unilateral peripheral vestibulopathy, absence of other neurological symptoms or signs (confirmed by ENT specialist or neurologist) occurring within 6-week risk period after first vaccination
Convulsion Seizures: Bonhoeffer et al. 2004 Brighton Definition
Level 1 of diagnostic certainty:
- Witnessed sudden loss of consciousness AND
- Generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations
Level 2 of diagnostic certainty:
- History of unconsciousness AND
- Generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations
Level 3 of diagnostic certainty:
- History of unconsciousness AND
- Other generalized motor manifestations
Severe allergic reaction Anaphylaxis: Ruggeberg et al. 2007 Brighton Definition
For all levels of diagnostic certainty:
Anaphylaxis is a clinical syndrome characterized by
- Sudden onset AND
- Rapid progression of signs and symptoms AND
- Involving multiple (>2) organ systems, as follows
Level 1 of diagnostic certainty:
- >1 major dermatologic AND
- >1 major cardiovascular AND/OR >1 major
respiratory criterion
Level 2 of diagnostic certainty:
- >1 major cardiovascular AND >1 major
respiratory criterion OR
- >1 major cardiovascular OR respiratory criterion
AND
- >1 minor criterion involving >1 different system
(other than cardiovascular or respiratory system)
OR
- (>1 major dermatologic) AND (>1 minor
cardiovascular AND/OR minor respiratory
criterion)
Level 3 of diagnostic certainty:
- >1 minor cardiovascular OR respiratory criterion
AND
- >1 minor criterion from each of >2 different
systems/categories i
Major criteria
Dermatologic or mucosal
- generalized urticaria (hives) or generalized
erythema
- angioedema i i , localized or generalized
- generalized pruritus, with skin rash
Cardiovascular
- measured hypotension
- clinical diagnosis of uncompensated shock, indicated by the combination of at least 3 of the
following:
o tachycardia
o capillary refill time >3s
o reduced central pulse volume
o decreased level of consciousness or loss of consciousness
Respiratory
- bilateral wheeze (bronchospasm)
- stridor
- upper airway swelling (lip, tongue, throat, uvula, or larynx)
- respiratory distress-2 or more of the following
o tachypnea
o increased use of accessory respiratory muscles (sternocleidomastoideus, intercostals, etc.)
o recession
The case definition should be applied when there is no clear alternative diagnosis for the reported event to account for the combination of symptoms not hereditary angioedema ii
o cyanosis
o grunting
Minor criteria
Dermatologic or mucosal
- generalized pruritus without skin rash
- generalized prickle sensation
- localized injection site urticaria
- red and itchy eyes
Cardiovascular
- reduced peripheral circulation as indicated by the combination of at least 2 of the following:
o tachycardia and
o a capillary refill time of >3s without hypotension
o a decreased level of consciousness
Respiratory
- persistent dry cough
- hoarse voice
- difficulty breathing without wheeze or stridor
- sensation of throat closure
- sneezing, rhinorrhea
Gastrointestinal
- diarrhea
- abdominal pain
- nausea
- vomiting
Laboratory
- mast cell tryptase elevation > upper normal limit
Encephalitis Sejvar et al. 2007 Brighton Definition
Level 1 of diagnostic certainty: Encephalitis
1. Demonstration of acute inflammation of central nervous system parenchyma (+/- meninges) by histopathology
Level 2 of diagnostic certainty: Encephalitis
1. Encephalopathy (e.g. depressed or altered level of consciousness, lethargy, or personality change lasting > 24 hours)
AND including
2. ONE or MORE of the following
a. Decreased or absent response to environment, as defined by response to loud noise or painful stimuli
b. Decreased or absent eye contact
c. Inconsistent or absent response to external stimuli
d. Decreased arousability
e. Seizure associated with loss of consciousness
OR
3. Focal or multifocal findings referable to the central nervous system, including one or more of the following
a. Focal cortical signs (including but not limited to: aphasia, alexia, agraphia, cortical blindness)
b. Cranial nerve abnormality/abnormalities
c. Visual field defect/defects
d. Presence of primitive reflexes (Babinski's sign, glabellar reflex, snout/sucking reflex)
e. Motor weakness (either diffuse or focal, more often focal)
f. Sensory abnormalities (either positive or negative, sensory level)
g. Altered deep tendon reflexes (hypo- or hyperreflexia, reflex asymmetry)
h. Cerebellar dysfunction, including ataxia, dysmetria, cerebellar nystagmus
AND (for both possibilities to reach level 2)
4. TWO OR MORE of the following indicators of inflammation of the CNS
a. Fever (temperature >38°C)
b. CSF pleocytosis (>5WBC/mm in children >2 months of age; >15 WBC/mm in children <2 months of age)
c. EEG findings consistent with encephalitis, or
d. Neuroimaging consistent with encephalitis
Level 3 of diagnostic certainty: Encephalitis
1. Encephalopathy (e.g. depressed or altered level of consciousness, lethargy, or personality change lasting >24 hours)
AND INCLUDING
2. ONE OR MORE of the following
a. Decreased or absent response to environment, as defined by response to loud noise or painful stimuli
b. Decreased or absent eye contact
c. Inconsistent or absent response to external stimuli
d. Decreased arousability, or
e. Seizure associated with loss of consciousness
OR
3. Focal or multifocal findings referable to the central nervous system, including one or more of the following:
a. Focal cortical sign (including but not limited to: aphasia, alexia, agraphia, cortical blindness)
b. Cranial nerve abnormality/abnormalities
c. Visual field defect/defects
d. Presence of primitive reflexes (Babinski's sign, glabellar reflex, snout/sucking reflex)
e. Motor weakness (either diffuse or focal, more often focal)
f. Sensory abnormalities (either positive or negative, sensory level)
g. Altered deep tendon reflexes (hypo- or hyperreflexia, reflex asymmetry)
h. Cerebellar dysfunction, including ataxia, dysmetria, cerebellar nystagmus
AND (for both possibilities to reach Level 3)
4. ONE of the following indicators of inflammation of CNS
a. Fever (temperature >38°C)
3b. CSF pleocytosis (>5WBC/mm in children
>2 months of age; >15 WBC/mm3 in children <2 months of age)
c. EEG findings consistent with encephalitis, or
d. Neuroimaging consistent with encephalitis
Level 3A of diagnostic certainty
1. Insufficient information available to distinguish case between acute encephalitis or ADEM, case unable to be definitely classified
Exclusion criterion for level 2 and 3 diagnostic certainty
1. other diagnosis for illness present
Myelitis Sejvar et al. 2007 Brighton Definition
Level 1 of diagnostic certainty: Myelitis
1. Demonstration of acute spinal cord inflammation (+/- meninges) by histopathology
Level 2 of diagnostic certainty: Myelitis
1. Myelopathy (development of sensory, motor, or autonomic dysfunction attributable to the spinal cord, including upper- and/or lower-motor neuron weakness, sensory level, bowel and/or bladder dysfunction, erectile dysfunction).
AND
2. TWO OR MORE of the following indicators suggestive of spinal cord inflammation:
a. CSF pleocytosis (>5 WBC/mm3 in children >2 months of age; >15 WBC/mm3 in children <2 months of age)
b. Neuroimaging findings demonstrating acute inflammation (+/- meninges), or demyelination of the spinal cord
Level 3 of diagnostic certainty: Myelitis
1. Myelopathy (development of sensory, motor, or autonomic dysfunction attributable to the spinal cord, including upper- and/or lower-motor neuron weakness, sensory level, bowel and/or bladder dysfunction, erectile dysfunction).
AND
2. ONE of the following indicators suggestive of spinal cord inflammation
a. CSF pleocytosis (>5nWBC/mm3 in children >2 months of age; >15 WBC/mm3 in children <2 months of age)
b. Neuroimaging findings demonstrating acute inflammation (+/- meninges), or demyelination of the spinal cord
Exclusion criterion for Levels 2 and 3 of diagnostic certainty
1. other diagnosis for illness present
Cases fulfilling the criteria for both encephalitis and myelitis in any category would be classified as encephalomyelitis
Acute disseminated encephalomyelitis (ADEM) Sejvar et al. 2007 Brighton Definition
Level 1 of diagnostic certainty: ADEM
1. Demonstration of diffuse or multifocal areas of (ADEM) demyelination by histopathology
OR
2. Focal or multifocal findings referable to the central nervous system, including one or more of the following:
a. Encephalopathy (see case definition for encephalitis for specification of encephalopathy)
b. Focal cortical signs (including but not limited to: aphasia, alexia, agraphia, cortical blindness)
c. Cranial nerve abnormality/abnormalities
d. Visual field defect/defects
e. Presence of primitive reflexes (Babinski's sign, glabellar reflex, snout/sucking reflex)
f. Motor weakness (either diffuse or focal, more often focal)
g. Sensory abnormalities (either positive or negative, sensory level)
h. Altered deep tendon reflexes (hypo- or hyperreflexia, reflex asymmetry)
i. Cerebellar dysfunction, including ataxia, dysmetria, cerebellar nystagmus
AND
3. Magnetic resonance imaging (MRI) findings displaying diffuse or multifocal white matter lesions on T2-weighted, diffusion-weighted (DWI), or fluid-attenuated inversion recovery (FLAIR) sequences (+/- gadolinium enhancement on T1 sequences)
AND
4. monophasic pattern to illness (i.e. absence of relapse within a minimum of 3 months of symptomatic nadir).
Level 2 of diagnostic certainty: ADEM
1. Focal or multifocal findings referable to the central nervous system, including one or more of the following:
a. Encephalopathy (see case definition for encephalitis for specification of encephalopathy)
b. Focal cortical signs (including but not limited to: aphasia, alexia, agraphia, cortical blindness)
c. Cranial nerve abnormality/abnormalities
d. Visual field defect/defects
e. Presence of primitive reflexes (Babinski's sign, glabellar reflex, snout/sucking reflex)
f. Motor weakness (either diffuse or focal, more often focal)
g. Sensory abnormalities (either positive or negative, sensory level)
h. Altered deep tendon reflexes (hypo- or hyperreflexia, reflex asymmetry)
i. Cerebellar dysfunction, including ataxia, dysmetria, cerebellar nystagmus
AND
2. Magnetic resonance imaging (MRI) findings displaying diffuse or multifocal white matter lesions on T2-weighted, diffusion-weighted (DWI), or fluid-attenuated inversion recovery (FLAIR) sequences (+/- gadolinium enhancement on T1 sequences)
AND
3. Insufficient follow-up time achieved to document absence of relapse within a minimum of 3 months of symptomatic nadir.
Level 3 of diagnostic certainty: ADEM
1. Focal or multifocal findings referable to the central nervous system, including one or more of the following:
a. Encephalopathy (see case definition for encephalitis for specification of encephalopathy)
b. Focal cortical signs (including but not limited to: aphasia, alexia, agraphia, cortical blindness)
c. Cranial nerve abnormality/abnormalities
d. Visual field defect/defects
e. Presence of primitive reflexes (Babinski's sign, glabellar reflex, snout/sucking reflex)
f. Motor weakness (either diffuse or focal, more often focal)
g. Sensory abnormalities (either positive or negative, sensory level)
h. Altered deep tendon reflexes (hypo- or hyperreflexia, reflex asymmetry)
i. Cerebellar dysfunction, including ataxia, dysmetria, cerebellar nystagmus
Level 3A
- Insufficient information is available to distinguish case between acute encephalitis or ADEM; case unable to be definitively classified.
Exclusion criteria for all levels of diagnostic certainty
- Presence of clear alternative acute infectious or other diagnosis for illness
- Recurrent relapse of illness at any point following a 3 month period of clinical improvement from symptomatic nadir, or
- If known, MRI findings or histopathology data inconsistent with the diagnosis of ADEM
Thrombocytopenia Wise et al. 2007 Brighton Definition
Level 1 of diagnostic certainty(confirmed TP)
- Platelet count less than 150 x 109/L
AND
- Confirmed by blood smear examination OR the presence of clinical signs and symptoms of spontaneous bleeding
Level 2 of diagnostic certainty (unconfirmed TP)
- Platelet count less than 150 x 109/L
Level 3 of diagnostic certainty
- Not applicable
Vasculitis Classification and Diagnostic criteria in systemic vasculitis Saleh and Stone 2005
Guillain-Barré syndrome According to Brighton definitions in preparation Brighton Definition in preparation
Bell's palsy Bell's palsy Gilden, 2004
Abrupt onset of unilateral facial weakness of peripheral cause in the absence of brain lesion and evidence for other causes of acquired peripheral facial weakness (diabetes, hypertension, HIV infection, Lyme disease, Ramsey Hunt syndrome, sarcoidosis, Sjögren syndrome, parotid nerve tumors, eclampsia, and amyloidosis) occurring within 6 weeks after first vaccination
REFERENCES
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Bonhoeffer J, Menkes J, Gold MS, de Souza-Brito G, Fisher MC, Halsey N, and Vermeer P. Generalized convulsive seizure as an adverse event following immunization: case definition and guidelines for data collection, analysis, and presentation. Vaccine 2004;22: 557-562.
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Ruggeberg JU, Gold MS, Bayas JM, Blum MD, Bonhoeffer J, Friedlander S, de Souza Brito G, Heininger U, Imoukhuede B, Khamesipour A, Erlewyn-Lajeunesse M, Martin S, Makela M, Nell P, Pool V, and Simpson N. Anaphylaxis: case definition and guidelines for data collection, analysis, and presentation of immunization safety data. Vaccine 2007;25:5675-5684.
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