Manual 18140473

Manual 18140473
c
0
CJ
@
@
@
@
G
0
0
Q
@
l1I
@
@
@
@
@
'h@
0
C}
G
c
G
©
@
@
@
@
@
©
@
0
0
0
©
l1I
l1I
@
@
l1I
@
©
©
G
0
@
©
G
0
G
()
0
Q
©
0
G
CJ
G
()
0
6
0
@
@
@
©
@
©
©
@
@
@
@
@
@
@
@
@
@
@
@
@
©
@
@
@
@
@
@
@
@
©
@
@
@
@
@
@
@
@
@
@
@
@
@
@
@
@
@
@
•
@
@
@
@
@
@
@
©
@
@
@
l1I
©
@
@
@
@
@
@
@
@
@
0
(')
Ci'
ISSN 0382-232X
Rapport hebdomadaire des
maladies au Canada
Canada Diseases
Weekly Report
Date of publication: 20 July 1991
Contenu du present numero:
Contained in this issue:
Adverse events temporally associated with immunizing agents1989 Report . . . . . . . . . . . . . . . .
Notifiable Diseases Summary . . . . . . . . . . .
147
152
ADVERSE EVENTS TEMPORALLY ASSOCIATED WITH
IMMUNIZING AGENTS-1989 REPORT
Effets secondaires relies dans le temps ades agents immunisants
(annae1989) . . . . . . . . . . .
Sommaire des maladies adeclaration obligatoire . . . . . .
147
152
EFFETS SECONDAIRES RELIES DANS LE TEMPS ADES AGENTS
IMMUNISANTS (ANNEE 1989)
a
Postmarketing surveillance of illnesses following receipt of
immunizing agents permits the following: (1) identification of illnesses of
infrequent occurrence that may be caused by immunizing agents; (2)
estimati9.n of rates of occurrence of more serious illnesses following
immunization by type of vaccine; (3) monitoring for unusually high rates
of adverse events; (4) raising health-care providers' awareness to the risks
and/or safety measures in administering vaccines; and (5) identification of
areas that require further epidemiologic research.
La surveillance des maladies survenues la suite de l 'administration d 'agents
immunisants apres leur mise en marche vise, dans I 'ensemble, les objectifs
suivants : 1) reperer les maladies peu frequentes qui pourraient etre causees par des
agents immunisants; 2) obtenir des estimations des taux de survenue des maladies
les plus graves, apres une immunisation, par typed 'agent; 3) rechercher les taux
anorrnalement elev es d 'effets secondaires; 4) serisibiliser les professionnels de la
sante aux mesures de securite appliquer et aux risques prevoir lors de
l'administration de vaccins; 5) reperer les domaines dans lesquels unerecherche
epidemiologique plus approfondie est necessaire.
) Surveillance for adverse events temporally associated with the
administration of immunizing agents at the federal' level is ihe
responsibility of the Bureau of Communicable Di~.ease Epidemiology
(BCDE), Laboratory Centre for Disease Control, Ottawa. The main
source of information is passive reporting by hea).th-care providers to
provincial or territorial authorities of events thought to be due to
administration of immunizing agents. These data, as well as information
from manufacturers and other agencies is forwarded to BCDE.
Au niveau federal, la surveillance des effets secondaires relies clans le temps a
l 'administration d 'agents immunisants releve du Bureau de l 'epidemiologie des
maladies transmissibles (BEM1) au Laboratoire de lutte contre la maladie
d 'Ottawa La principale source d'information est la declaration passive: les
professionnels de la sante informent les autorites provinciales et territoriales des cas
juges attribuables a I' administration d'agents immunisants. Ces donnees, de meme
que I 'information provenant des fabricants et d 'autres organismes, sont envoyees au
BEMT.
A computerized database has been established that includes
epidemiologic and medical information on reported events related to
patients vaccinated since 1 January, 1987. To be included in the database,
reports had to meet the criteria in Appendices I and II and could not be
attributable to any co-existing conditions. Acceptance of a report did not
imply a causal relationship between the administration of the immunizing
agent and the medical outcome or that the report was verified as to
accuracy of content. The sensitivity, specificity and timeliness of the
reporting system vary greatly by province/territory. Within a province,
these factors vary by type of vaccine delivery system (public versus
private).
Une base de donnees informatisee a ete etablie. On y retrouve les
renseignements epidemiologiques et medicaux SUI les manifestations signalees chez
des sujets immunises depuis le 1er janvier 1987. Pour y etre incorpores, les rapports
doivent repondre aux criteres enonces clans les annexes I et II et ne pas etre
attribuables a une affection coexistante. L 'acceptation d 'un rapport ne signifie pas
qu 'il y ait une relation caus ale entre l' administration de l' agent immunisant etla
reaction en cause, ni qu 'on ait verifie l' exactitude des renseignements foumis. La
sensibilite et la specificite de la declaration et la rapidite de la production, des
rapports varient grandement d'une province OU d'un territoire l'autre. A
l 'interieur d 'une province, ces facteurs varient selon que le systeme
·
d'administration des vaccins est public ou prive.
The following is the third yeariy national summary on adverse events
temporally associated with the adminstration of immunizing agents and
deals with reports pertaining to immunization events between 1 January
and 31 December, 1989 that were forwarded to BCDE by 31 September,
1990. It also compares some of the 1989 figures with those published for
1988 Cll and 1987 12l.
·
Le present document est le troisieme rapport annuel national portant sur les
effets secondaires relies dans le temps al'administration d'agents irnmunisants. 11
traite des rapports d 'effets secondaires relies ades vaccins administres du 1er
janvier au 31 decembre 1989, qui ont ete signales au BEMT avant le 31 septembre
1990. On y compare egalementles chiffres de 1989 avec ceux qui ont ete publies
pour 1988(1) et 1937<2l.
.
Among the reports that were accepted, some contained information on
more than one immunizing agent or more than one adverse event for a
given patient. For this reason, the number of individual reports analyzed
(2,403 - 9.2/100,000 population) is less than the number of associated
agents (3,602) and the number of adverse events reported (also referred to
Parmi les rapports acceptes, certains renferment des renseignements surplus
d 'un agent immunisant ou plus d 'un effet secondaire chez un sujet donne. Cela
explique que le nombre des rapports individuels analyses (2 403, soit 9,2 pour
100 000 habitants) est inferieur a celui des mentions d 'agents incrimines (3 602) et
au nombre d'effets secondaires signales (3 109). Le nombre d'effets secondaires
,,,
'
Date de publication: 20 juillet 1991
Vol. 17-29
!SecondClu11.WlReglltn.tiooNo. ~670
..I
a
a
I
Health and Welfare
Canada
---~
a
JOJli"rli&lidimi!mc:ClJJ1c·Elirt&lfiit.Uimtn•:S670
Santa et Bien-4tre social
Canada
147
I
Canada
as the number of adverse event citations) (3, 109). The number of
adverse events associated with a specific agent represents all reports in
which this agent was one of those given to the patient.
relies aun agent donne correspond au nombre de rapports dans lesquels cet
agent figure parmi ceux qui ont ete administres.
For 1989, 2,403 (78.7%) of3,052reportsreceived met the eligibility
criteria compared with 58% and 51 % of all reports received for 1988
and 198?,respectively.
Pour l'annee 1989, 2 403 (78,7 %) des 3 052 rapports obeissent aux criteres
d'inclusion. En 1988 et en 1987, ce pourcentage s 'etablissait a58 % et a 51 %
respectivement
GEOGRAPHIC DISTRIBUTION
REPARTITION GEOGRAPHIOUE
Figures 1 and 2 show the distributions of the numbers of reports
analyzed and the rates of adverse event reports per 100,000 population
(according to 1987, 1988, and 1989 post-censal estimates) per
province/territory for 1987, 1988, and 1989, respectively. The
distributions differ from what one might expect on the basis of
population alone and this is probably due in part to differences in
provincial/territorial reporting systems. These differences make it
difficult to compare the data between the provinces. For example, the
more active nature of the system in place in Alberta may explain the
high rate of reporting in that province. However, it is important to point
out that Alberta, which accounted for 56% of all reports analyzed for
the year 1987, accounted for only 39% of those analyzed in 1989. This
Les Figures 1 et 2 illustrent la repartition des nombres de rapports analyses
et les taux de rapports sur des effets secondaires pour 100 000 habitants (suivant
les estimations postcensitaires pour 1987, 1988et1989) par province ou
territoire pour 1987, 1988 et 1989 respectivement. Si ces chiffres dif!erent de
ceux auxquels on pourrait s 'attendre en se fondant uniquement sur la
population, c'estprobablement, du mains en partle, a cause des differences dans
les systemes de declaration entre provinces et territoires. Ces differences
rendent difficile toute comparaison de donnees entre les provinces. Par
exemple, la nature particulierement active du systeme en place en Alberta peut
expliquer le taux eleve de declarations faites dans cette province. Il est toutefois
important de remarquer que I 'Alberta, qui avait presente 56 % de tousles
rapports analyses pourl'annee 1987, n'en a presente que 39 % en 1989. Cela
Figure 1
Vaccine-Associated Adverse
Events: Number of Reports
Analyzed by
ProvmcefTerritory, Canada,
1987-1989
Number of Reports
Nombre de rapports
1400
-
1987
t:z:J 1988
CJ 1989
1200
Figure 1
Effets secondaires relies a
des vaccins : nombre de
rapports analyses par
province/territoire (Canada
1987-1989)
(rapports rec;us jusqu'en
septembre 1990)
(reports received as of
September 1990)
Alta · BC Ont Sask Que ,PEI, NB Yukon Man Nfld NS, NWT
Qu(I l·P·E
T·N N·E TN-0
Alb c.-8.
Province/Territory
Figure 2
Vaccine-Associated Adverse
Events: Reports Analyzed
per 100,000 Population, by
Provincerrerritory, Canada,
1987-1989
Province/territoire
Figure 2
Effets secondaires relies a
des vaccins : nombre de
rapports analyses pour
100 000 habitants par
province/territoire (Canada
1987-1989)
Reporte/100,000 Population
Rapporta/100 000 habitants
100
-
1987
t:z:J 1988
CJ 1980
80
60
(rapports rec;us jusqu'en
septembre 1990)
(reports received as of
September 1990)
Alta
Alb
BC
c.-B.
Ont Sask Que PEI, NB Yukon Man Nfld NS, NWT Can
Qu6 l.-P.-E.
T.-N. N.-E. T.N.-0.
h
Province/Territory
Province/territoire
148
(
indicates a trend toward a better
representation of other
provinces/territories in the database.
In addition, reporting practices can
'so vary considerably from one
ia!th unit to the other within a
province.
AGE/SEX DISTRIBUTION
The age distribution of
immunizing agent-associated adverse
event reports indicates that most
reactions occurred among children
under one year of age (Table 1).
Given that childhood immunization
programs across the country
emphasize early immunization <3l, it is
not unexpected to find that most
adverse event reports (54.1 %) were
from this group. The second most
commonly affected age group was the
1-4-year-olds, identified in 26.1 % of
the reports. Children less than 2 years
accounted for 70. 7% of all patients.
The median age was 0.6 year and the
mean age 4.2 years.
Table 1 /Tableau 1
Distribution of Immunizing Agent Temporally Associated
Adverse Event Reports By Age Group, Canada, 1989
Effets secondaires relies dans le temps a des agents
immunisants : rep11rtition des rapports selon les tranches
d'age (Canada 1989)
~ge
Frequency
Frequence
Age
00-01 Month I Mois
02-03
04-05
06-07
08-09
10-11
12-23
02-04 Years/ Ans
05-09
10-19
20-29
30-39
40-49
50-59
60+
78
439
378
282
84
38
401
226
188
44
53
64
54
24
31
19
2,403
Unknown/ lnconnu
TOTAL
Percent
Pourcentage
3.3
18.4
15.9
11.8
3.5
1.6
16.8
9.5
8.0
2.0
2.2
2.7
2.3
1.0
1.3
0.8
100.0
indique que d'autres provinces ont
ameliore leur declaration. Les sysremes
de declaration peuvent egalement varier
considerablement d 'un service de sante a
l' autre dans une province donnee.
REPARTITION PAR AGE ET PAR SEXE
La plupart des reactions ont ere
observees chez des enfants de moins d 'un
•an (Tableau 1). Etant donne que les
programmes de vaccination des enfants,
d'un bout al'autre du pays, accordentune
grande importance a la vaccination
. precoce (3}' il n 'est pas smprenant de
constater que la plupart des effets
secondaires signales (54,1 %) sont
survenus dans ce groupe. Puis viennent
les enfants de 1 a 4 ans, soit 26, 1 % des
rapports; ceux de moins de 2 ans
representent 70,7 % de !'ensemble. L'age
median est 0,6 an, l 'age moyen 4,2 ans.
Table 2 I Tableau 2
Distribution of Immunizing Agent Temporally Associated Adverse Event Reports By Immunizing Agent, Canada, 1989*
Effets secondaires relies dans le temps a des agents immunisants : repartition des rapports selon l'agent immunisant (Canada 1989)*
Immunizing Agent
Frequency
(Cases hospitalized)
Frequence
(nombre de cas
hospitalises)
Agent immunisant
.Jlphtheria, Pertussis, Tetanus (DPT) I Diphterie, coqueluche, tetanos!(DCT)
1,592(82)
Oral Poliovirus Vaccine (Sabin) (OPV)(2) /Vaccin antipoliofnyetilique par voie buccale (Sabin)(2)
1,025(59)
Diphtheria, Pertussis, Tetanus, Polio (DPTP) /Diphterie, Cf>queluche, tetanos, polio (Salk) (DCPT)
291(33)
Haemophilus influenzae Type b (Hib) I Haemophilus influehzae du type b (Hib)
171(16)
Measles, Mumps, Rubella (MMRVac) I Rougeole, oreillons, rubeole (ROR)
168(29)
Hepatitis B (HB) I Hepatite B (HB)
72(3)
Influenza (FLU) I Grippe (Flu)
62(6)
Tetanus, Diphtheria (adults) (Td) /Tetanos, diphterie, (adultes) (fd)
52
Diphtheria, Tetanus (children) (DT) I Diphterie, tetanos (enfants) (OT)
39(2)
Tetanus, Diphtheria, Poliovirus (TdP)/Tetanos, diphterie, polio (TdP)
22(1)
Typhoid (TYPH) /Typho'ide (Typh)
21(1)
Rubella (R) I Rubeole (R)
17(1)
Diphtheria (D) I Diphterie (D)
11
Purified Protein Derivative (PPD) I Derive prot~nique purifie de tuberculine (OPP)
8(1)
Diphtheria, Pertussis, Tetanus, Polio, Hib (DPTPH) I Diphterie, coqueluche, tetanos, polio, Hib (DCTPH)
7
Pertussis (P) I Coqueluche (C)
6
Rabies (RAB) I Rage (RAB)
6(1)
Inactivated Poliovirus (Salk) (IPV)/Vaccin antipoliomyelitique inactive (Salk)
5
Immune Globulin (IG) / lmmunoglobuline (lg)
5
Yellow Fever (VF) I Filivre jaune (Fj)
4(1)
Bacille Calmette-Guerin (BCG) I Bacille Calmette-Guerin (BCG)
4(2)
Pneumococcal (PNEUMO) /Vaccin anlipneumococcique (Pneumo)
4
Meningococcal Polysaccharide Vaccine'(MENING) /Vaccin antimeningococcique polysaccharidien (Mening)
4
Tetanus (T) I Tetanos (T)
3
Cholera (CHOL) I Cholera (Chol)
1
Measles (M) I Rougeole (Roug.)
1
Mumps (MUMPS) /Oreillons (0)
1
TOTAL
3,602
(1)
(2)
Estimates for the numbers of doses distributed are based on information from
manufacturers.
Two cases were contacts of individuals who were given oral poliovirus vaccine.
The DPTPH was not licensed and was sole~ used for trials. The number of doses
distributed cannot, therefore, be used and the rate released in this report.
Because of the very low reporting of adverse reactions to immune globulins through
the spontaneous reporting system, It would be meaningless to try to provide a rate.
Includes all associated agents given at that time.
(1)
(2)
(3)
(4)
Percent
Pourcentage
44.2
28.5
8.1
4.8
4.7
2.0
1.7
1.4
1.1
0.6
0.6
0.5
0.3
0.2
0.2
0.2
0.2
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.0
0.0
Rate/100,000 DRf es
Distributed
Tauxpour100 00~ foses
.distribuees 1
104.8
45.0
29.2
32.0
27.3
22.2
2.4
6.4
34.3
3.6
19.5
28.7
81.7
0.7
_(3}
44.3
58.3
4.5
_(4)
5.1
6.3
20.6
5.5
0.8
1.3
3.3
9.6
100.0
Les estimations du nombre de doses distribuees se fondant sur des renseignements
communiques par !es fabricants.
Deux sujets ont ete en contact avec des individus qui avaient re~u le vaccin buccal contre la
polio.
Le DCTPH, qui n'est pas encore approuve, a ete utilise uniquement dans le cadre d'essais.
Le taux pour 100 000 doses distrib~ees ne peut done pas litre etabli dans le present rapport.
Etant donne que le nombre d'effets secondaires relies a!'administration d'immuno9.lobuline
signales par le truchement du systeme de declaration volontaire est tres faible, ii nya pas
lieu de fournir un taux.
lnclut tous !es agents administres en ~me temps.
'149
The number of males
reported to have had at least
one adverse event associated
with an immunizing agent
was 1,197 (50.1%). In 14
reports, the patient's sex was
unknown so these reports
were excluded from the above
calculation.
Table 3 I Tableau 3
Distribution Of Immunizing Agent Temporally Associated Adverse
Event Reports By Selected Immunizing Agent, Canada, 1987·1989
Effets secondaires relies dans le temps a des agents immunisants:
repartition des rapports selon le vaccin (Canada 1987-1989)
lmm.mizing Agent
Frequency(rate/100,000 doses)
(distributed)
Frequence (taux/100 000 doses)
distribuees
Vaccin
IMMUNIZING AGENTS
Table 2 presents the
distribution of adverse event
reports by type of
immunizing agent Of the
reports involving OPV, only 2
indicated an adverse event
after OPV was given alone.
In addition 2 reports pertained
to contact cases of immunized
children. In all other cases,
OPV was given at the same
time as another vaccine
(usually DPT) and any
adverse event could possibly
be attributed to the other
vaccine. The much higher rate for
DPT compared to DPTP is
presumably because DPT is the
vaccine used in those provinces
which have the highest reporting
rates.
1987
DPT/OCT
OPV /Sabin
DPTP/DCTP
Hib
MMRVac/ROR
HB
FLU/Flu
Td
OT
TdP
TYPH /Typh
Table 3 compares the
distribution of immunizing
agent-associated adverse event
reports by selected immunizing
agent for 1987, 1988, and 1989.
Table 4 shows the various antigen
combinations listed in the reports
and assists in the interpretation of
Table2.
ADVERSE EVENTS
The number of adverse events
reported in each adverse event
category is presented in Table 5 (see
Appendix I for a detailed
description of the adverse event
categories). The most commonly
reported adverse event was fever
(all fever categories combined),
cited in 1,217 reports (50.6%). Of
these, 126 (10.4%) indicated a
temperature greater than or equal to
40.5'C,
Table 6 presents the distribution
of adverse events by antigen
administered. It provides only
figures for those immunizing agents
that were mentioned on more than 5 _
reports. It is important to point out
that there was no attempt to attribute
the event to a specific antigen of a
combination and that reactions were
tabulated for each antigen if that
antigen was among those
administered to the patient. This
does not imply a relationship with
that antigen. It is particularly true
for OPV which is usually given in
association with other vaccines.
1,179
689
227
48
511
13
34
39
26
12
15
(69.4)
(43.1)
(32.4)
(12.6)
(124.6)
(6.8)
(2.3)
(6.6)
(33.8)
(1.9)
(78.9)
1,546
916
365
126
323
48
40
30
25
36
17
AGENTS IMMUNISANTS
1989
1988
(77.7)
(56.0)
(43.1)
(22.6)
(40.6)
(18.7)
(1.9)
(6.1)
(5.7)
(1.0)
(12.3)
1,591
1,025
291
171
168
72
62
52
39
22
21
(104.8)
(45.0)
(29.2)
(32.0)
(27.3)
(22.2)
(2.4)
(6.4)
(34.3)
(3.6)
(19.5)
Table 4 I Tableau 4
Distribution of Immunizing Agent Temporally Associated
Adverse Event Reports by Combinations of Products
Administered, 1989, Canada
Effets secondaires relies dans le temps a des agents
immunisants : repartition des rapports selon la combinaison
de produits administres (Canada 1989)
Frequency
Vaccine
Frequence
Yaccin
One product given: I Un produit a ete administre:
DPT I OCT
DPTP I DCTP
MMRVac'?ROR
HB/HB .
580
274
150
TI
i
RU/Fl~
Le nombre des sujets masculins
chez qui l 'on a observe au moins un
effet secondaire est de 1 197
(50,1 %). On exclut de ce calcul 14
rapports n 'indiquant pas le sexe du
sujet.
Le Tableau 2 presente la
repartition des rapports d 'effets
secondaires par antigene. Parmi les
rapports dans lesquels on fait
mention du vaccin
antipoliomyelitique buccal, 2
seulementindiquent un tel effet
apres !'administration de ce vaccin
seul. En outre, 2 rapports font
mention de sujets ayant ete en
contact avec des enfants ayant regu
ce vaccin. Dans tousles autres cas,
il avait ete donne en meme temps
qu 'un autre vaccin (habituellement le
DCT): les effets secondaires
pourraient etre attribues acet autre
vaccin. Le taux beaucoup plus eleve
pour le DCT que pour le DCTP resulte
probablement de ce qu 'on utilise le DCT
dans les provinces qui ont les taux de
declarations les plus eleves.
Dans le Tableau 3, on compare pour
1987, 1988et1989 larepartition des
rapports d'effets secondaires pour des
vaccins choisis. Le Tableau 4 donne la
liste des diverses associations de produits
mentionnees dans les rapports et facilite
!'interpretation du Tableau 2.
~
Td/Td 1
Hib I Hib:·
TdP/Tdp
DT/DT,
TYPH /Typh
R/R
DPTPH I DCTPH
PPD I OPP (tuberculine)
RAB/ Rab
BCG/BCG
37
32
22
17
17
16
7
6
6
4
4
4
3
3
2
2
2
DID
IG/lg
PNEUMO/Pneumo
TIT
MEN ING
OPV /Sabin
OPV-C I Sabin (contact)
YF I FJ
PI C (coqueluche)
RIG I Rig
EFFETS SECONDAIRES
Le nombre d 'effets secondaires
signales dans chaque categoiie est
presente dans le tableau 5 (voir a
l'Annexe I la description detaillee de ces
categories). Le plus communement
signale est la fievre (toutes les categories
relatives ala fievre etant combinees),
declaree dans 1 217 rapports (50,6 %).
Parmi ces declarations, 126 (10,4 %)
indiquent une temperature d 'au moins
40,5'C.
2
2
1
1325 TOTAL
Two products given: I Deux produits ont ete sdministres:
DPT I OCT
OPV I Sabin
DPT I DCT
Hib
DPTP I DCTP Hib
OT IDT
OPV /Sabin
Other combinations I Autres combinaisons
Td/TD
OPV /Sabin
DPT/OCT
MMRVac/ROR
878
19
17
17
14
8
6
959 TOTAL
Three products given :I Trois produits ont ete sdministres :
DPT I OCT
OPV I Sabin
Hib
Other combinations I Autres combinaisons
DPT /OCT
OPV /Sabin
MMRVac/ROR
98
10
9
Four products given :I Qustre produits ont ete sdminist;es :
DPT I OCT
OPV I Sabin
Hib
MMRVac I ROR 2
150
117 TOTAL
2 TOT AL
On peut voir au Tableau 6 la
repartition des effets secondaires par
antigene. Les chiffres sont donnes
uniquement pour les agents immunisants
mentionnes dans plus de 5 rapports. Il
est important de noter qu 'on n'a pas tente
d 'attribuer la manifestation aun antigene ·
particulier dans une association
d'antigenes. Les reactions sont indiquees
dans le tableau pour chaque antigene de
!'association sans prejuger d 'un rapport
avec cet antigene. Ceci est
particulierement important dans le cas du
vaccin antipoliomyelitique buccal qui est
habituellement administre en association
ad'autres vaccins.
c._
Table 5 /Tableau 5
Distribution of All Citations of Immunizing Agent Temporally Associated Adverse Event Reports By Nature of Adverse Event, Canada, 1989
Effets secondaires relies dans le temps a des agents immunisants : repartition des rapports suivant la nature des effets secondaires
(Canada 1989)
Reports/ 100,000 Doses Distributed..
Adverse Event'
Frequency
Percent
'ffets secondaires'
Frequence
Pourcentage
Taux/ 100 000 doses distribuees"
Fever I Fievre
Screaming Episode I Cris
Allergic Reaction I Reaction allergique
Severe Vomiting and/or Diarrhea I Vomissements graves et (ou) diarrhea
Severe Local Reaction I Reaction locale grave
Other Events I Autres manifestations
Hypotonic,-Hyporesponsive Episode I Episode d'hypotonie I hyporeactivite
Rashes I Eruption
Convulsion/Seizure I Convulsion
Sterile Abscess/Nodule/Necrosis I Abses sterile/nodule/necrose
Arthralgia/Arthritis I Arthralgie/arthrite
Adenopathy I Adenopathie
Parotitis I Parotidite
Anaesthesia/Paresthesia/ Anesthesie/paresthesie
Anaphylaxis I Anaphylaxie
Infective Abscess I Abces infectieux
Encephalopathy /Encephalopathie
Thrombocytopenia/Thrombocytopenie
Paralysis I Paralysis
Guillain-Barre Syndrome I Syndrome de Guillain-Barre
Meningitis and/or Encephalitis I Meningite et (ou) encephalite
Orchitis I Orchite
TOTAL
For definitions, see Appendix I.
Estimated number of doses distributed used in the above calculation= 12,600,000.
(
1,217
720
167
150
149
148
132
114
99
39.2
23.2
5.4
4.8
4.8
4.8
4.2
3.7
3.2
2.3
1.3
1.3
0.6
0.4
0.4
0.3
0.0
0.1
0.1
0.1
0.0
0.0
100.0
72
41
39
18
13
12
9
0
3
3
2
1
0
3,109
9.7
5.7
1.3
1.2
1.2
1.2
1.0
0.9
0.8
0.6
0.3
0.3
0.1
0.1
0.1
0.1
0.0
0.0
0.0
0.0
0.0
0.0
24.7
Vair Jes definftions a!'Annexe I.
Nornbre estime de doses distribuees utilise dans le calcul = 12 600 000.
Table 7 compares the frequencies of selected vaccine-associated
adverse events for 1987, 1988, and 1989.
Le Tableau 7 etablitune comparaison entre les frequences de certains effets
secondaires associes 8.l'administration de vaccins en 1987, 1988et1989.
The delay between administration of the immynizing agent and
nset of adverse event ranged from 1 minute to 99 days. Only 205
(9 .9%) reactions occurred less than 2 hours after t,he immupizing agent
was administered, 1131 (54.4%) from 2 to 11 hours after, 1336 (64.3%)
less than 12 hours after, 223 (10.7%) from 12 boars to 24 hours after,
1559 (75.0%) less than one day after, 208 (10.0%) one day after, 151
(7.2%) from 2 to 6 days after, 149 (7.2%) from 7,days to one month
after, and only 9 (0.4%) after one month (most of these were nodules).
Information was missing on 329 reports. The median delay was
approximately 6 hours. These figures have to be interpreted with
caution since they largely reflect the temporal inclusion criteria that
were used.
L 'intervalle de temps ecoule entre la vaccination etl' apparition de l 'effet
secondaire va de 1 minute a 99 jours. Seulement 205 (9,9 %) reactions se sont
produites moins de 2 heures apres !'administration; 1 131 (54,4 %) sont
survenues au bout de 2 a 11 heures, soit 1 336 (64,3 %) moins de 12 heures
apres; 223 (10,7 %) dans les 12 a24 heures soit 1 559 (75,0 %) dans les 24 h.;
208 (10,0 %) lelendemain, 151 (7,2 %) de 2a 6 jours apres, 149 (7,2 %) de 7
jours a 1 mois apres et seulement 9 (0,4 %) plus d 'un mois apres (dans la plupart
des cas il s'agit de nodules). Dans 329 rapports il n 'est pas fait mention du
temps ecoule. L 'intervalle median est d 'environ 6 heures. Il faut interpreter ces
chiffres avec prudence puisqu 'ils sont largementinfluences par les criteres
d 'inclusion en fonction du temps.
DPT and DPTP DOSE NUMBER IN SERIES
OCT et DCTP : NUMERO D'ORDRE DE LA DOSE DANS LA SERIE
Dans la troisieme edition du Guide canadien d 'immunisation<3>, on
The third edition of the Canadian Immunization Guide<3l
recommends that children be immunized with DPT or DPTP at 2, 4, 6,
and 18 months with a booster between 4-6 years of age.
recommande d 'administrer les vaccins DCT ou DCTP aux enfants a 2, 4, 6 et 18
mois et une injection de rappel entre 4 et 6 ans.
The distribution of DPT and DPTP-associated adverse event reports
by dose number in series (fable 8) indicates that the frequency of
reported adverse events decreases with each subsequent dose.
Assuming that almost all children receive all 4 doses of the primary
series and most receive the 1 booster dose as well, the frequency of
administration of all 5 doses should be similar in any given year. If the
denominatoris stable, the observed decline in the number ofreported
adverse events as the dose number in the series increases implies that
reaction rates to DPT vaccine decrease with increasing dose number.
Since this conclusion is contrary to the general belief that the rate of
reaction increases with the dose number in series, possible other
explanations for the observation must be explored. It may be that
health-care personnel advise those experiencing a significant reaction to
discontinue the series since they have the highest likelihood of
experiencing further significant reactions on subsequent doses. Our
observation may also be due to decreasing ascertainment of adverse
1ents with increasing age. Children over 1 year of age have less
La repartition des rapports d 'effets secondaires relies dans le temps au DCT
et au DCTP, selonl'ordre del'injection dans la serie (Tableau 8), montre que
leur frequence diminue pour chaque dose successive. Sil 'on tient pour acquis
que presque tousles enfants re~oivent les 4 doses de la serie primaire, et quela
plupart re~ivent egalement 1 dose de rappel, on suppose que la frequence
d'administration delaserie complete- soit 5 doses-est stable d'une annee a
l 'autre. Si ce denominateur est stable, la diminution du nombre de signalements
d 'effets secondaires amesure qu'augmentele numero d'ordre de !'injection dans
la serie semble representer un phenomene reel. Comme ceci va al' encontre de ce
qui est generalement admis, il faut trou'Ver d'autres explications. Le personnel
soignant conseille peut-etre aux sujets qui reagissent fortement de ne pas
completer la serie du vaccin, puisque ces sujets presentent le risque le plus eleve
de reactions importantes aux doses subsequentes. Ou bien on a peut-etre moins
ten dance arapporter les reactions amesure que I 'age augmente. Comme les
enfants de plus d'un an ont moins de contacts que leurs cadets avec les services
de sante, les effets secondaires chez eux risquent davantage de ne pas etre portes
a!'attention des professionnels d€? la sante et de ne pas etre declares. Mais il
Suite
Continued on page 154
151
ala page 154
HEALTH AND WELFARE CANADA - SANTE BIEN-ETRE SOCIAL CANADA
Notifiable Diseases Summary-Sommalre des ma ladles declaration obllgatolre
New Cases Reported for the Month Ending February 28, 1991
Nouveau cas declares pour le mols se termlnant le 28f9vrler1991
a
Disease
Maladle
ICD·9 Canada
CIM·9
AIDS-Sida
042·044
006
005.1
023
008.41'
099.0
052
099.81'
001
032
007.1
098
Amoebi~is • Amibiase
Botulism· Botulisms
Bruoellosls • Brucellose
Campylobacteriosis • Campylobacleriose
Chancroid ·Chancre mou
Chickenpox • Varioelle
Chlamydia, genital· Chlamydiose genitals
Cholera· Cholera
Diphtheria· Diphterie
Giardiasis • Giardiase
Gonococcal Infections Infections gonocccciques
Gonococcal Ophthalmia neonatorum Ophtalmie gonococcique du nouveau-ne
Haemophilus influenzas 8 (all invasive) (invasive) a H. Influenzas B
Hepatitis A - Hepattte A
Hepatitis B • Hepattte 8
Hepatitis C - Hepatite C
Hepatitis non-A, non-8 •
Hepatite non·A, non·B
Herpes Simplex (congenital/neonatal) Herp8s (congenitaVneonatal)
Leglonellosls • Legionellose
Leprosy - Lepre
Listeriosis (all types) Llsteriose (lous genres)
Malaria - Paludisme
Measles - Rougeole
Meningitis, pneumococcal Menlngite apneumocoques
Meningitis, other bacterial
Autres mtiningites bacttiriennes
Meningitis/Encephalitis viral·
Meningite/enoophaltte virale
Meningococcal Infections·
Infections a menlngocoques
Mumps • Oreillons
Paratyphoid - Paratypho!de
Pertussis· Coqueluche
Plague - Pesta
Poliomyelitis· Poliomyeltte
Rabies - Rage
Rubella - Rubtiole
Congenital Rubella·Rubeole congenltale
Salmonellosis • Salmonellose
Shlgellosis • Shigellose
Syphilis:
Early, SymptomaticSymptomalique, recente
Other Syphilis - Autres syphilis
Tetanus - Tetanos
Trichinosis- Trichinose
Tuberculosis - Tuberculeuse
Typhoid- Typhoids
Verotoxigenic E. coli - E. coli
veroloxinoglmes
Yellow Fever- Fievre jaune
.,,
(1)
(2)
(3)
(4)
(5)
.f6l
Cur.
Cou.
8
146
-
-
-
581
1288
-
-
-
357
-
10
16
-
-
-
-
14
-
2
10
-
4103
1050
65
47
79
47
238
-
-
-4
-
-
-
658
890
1377
1987
678
1043
3
3
10
7
7
1
10
-
-
-
-
-
-
-
-
-
41
23
070.0,Q?0.1
070.2,070.3
115
210
1
2
270
416
1
11
233
205'
12
-
-
54
397
14
14
29
19
-
6
15
8
9
26
21
75
·-
-
-
-
-
-
-
-
16
-
-
-
.i3
23
3
5
-
50
3
538
48
-
-
5
-
420
-
-
-
2
-
-
3
-
-
-
-
-
38
930
211
65
33
1
472
99
20
142
22
-
-
-
2
54
5
14
3
119
6
52
-
-
-
-
-
-
-
-
-
-
-
-
-
1
-
-
-
-
-
-
-
(1)
(2)
(3)
(4)
(5)
f6)
-
3
6
28
-
-
-
-
-
-
-
4
7
-
10
19
-
-
-
-
-
-
-
-
-
-
-
-
-
1
4
1
-
-
-
-
1
18
13
-
'·
15
9
-
-
-
1
30
25
-
-
-
-
..
..
..
..
..
..
..
..
..
..
..
..
..
..
..
..
..
..
..
..
..
..
..
..
..
..
..
..
..
..
..
..
-
-
-
1
1
3
-
-
-
-
21
34
-
-
-
4
-3
-
-
-
-
-
-
-
2
-
-
4
-
-
-
-
-
12
1
7
-
-
1
1
-
-
-
-
-
-
-
-
-
-
-
-
-
14
2
-
-
12
1
2
-
-
-
35
4
3
-
37
1
7
-
-
1
2
1
-
-
-
-
-
-
-
-
-
1
2
-
-
-
-
-
-
-
-
31
-
-
-
..
5
-
-
..
-
1
-
-
3
-
-
-
-
-
-
5
-
..
..
-
-
-
-
3
-
-
-
-
..
..
..
..
-
2
-
-
-
-
-
..
..
..
..
..
..
-
2
-
..
..
..
..
..
..
..
..
..
..
..
..
-
-
1
-
-..
..
..
..
..
..
..
..
..
..
..
..
..
..
..
..
..
..
-
-
-
-
-
-
-
-
-
-
-
1
-
-
-
-
3
2
-
1
-
1
-
-
-
-
-
-
-
4
38
-
-
-
-
-
21
-
-
4
39
294
1
-
-
54
381
-
-
-
-
-
-
-
-
22
-
32
-
-
19
-
-
-
12
-
6
-
Includes all 098 categories except 098.4
Includes buccal oellulitis or epiglottitis 464.3 in a child < 6 yearo with no other causative
organisms Isolated
Includes encephalitis
All other categories except Haemophilus 320.0, Llsteriosis 027.0,
Menlngococcal 036, Pneumococcal 320.1 and Tuberculosis 013.0
All categories except Measles 055, Mumps 072, Poliomyelitis 045, Rubella 056
and Yellow Fever 060
Excludes Typhoid 002.0 and Paratyphoid 002.1 lo 002.9
ICD·9 codes used in the list may be incorrplete. All 5 digit codes are unofficial and
are for LCDC surveillance purposes only.
-
-
-
1
-
1
-
94
-
-
-
-
26
161
7
,.31
20
6
-
-
9
-
15
175
-
-
13
79
-
-
-
-
40
-
13
-
11
-
-
-
-
18
-
084
055
320.1
-
-
-
2
-
1
-
15
21
-
14
3
..
-
-
-
1
1
7
072 ' 24
002.1·002.9' \
3
033
187
;
020
045
071
-'
056
16
771.0
003
393
004
105
091
31
-
-
-
-
-
1
2
-
1
1
1
482.81
030
027.0,771.22'
2
2
-
-
-
771.21'
060
-
2364
4333
21
090,092·097
037
124
010·018
002.0
008.01'
-
-
1024
2030
098.4
"'
•
-
-
-2
320.0,038.41'
036
'
Newfoundland
Prince Edward Island
Nova Scotia
New Brunswick
Quebeo
Terre·Neuve
lle·dU·Prince·Edouard Nouvelle·Ecosse
Nouveau-Brunswick
Quebec
Cum •. Cum.'
Cur. Cum. Cum.'
Cur. Cum. Cum.'
Cur. Cum. Cum.•
Cur. Cum. Cum.•
Cur. Cum. cul
91
90 Cou.
91
90 Cou.
91
90 Cou.
91
90 Cou.
91
90 Cou.
91
~77
238
1
2
5
290
2
131
2
-
2
-
-
-
-
-
-
-
..
.
-
(
-
-
-
-
-
..
..
..
..
..
-
-
.
-
Comprend loutes les rubriques 098, sauf 098,4
Comprend cellulite buccale ou epiglotttte 464,3 chez un enfant < 5 ans chez qui
aucun autre microorganisms causal n'a ate isole
Comprend enoophaltte
Toutes las autres rubriques sauf Haemophlllus 320,0, listeriose 027,0,
a rneningocoques 036, apneumocoques 320, 1 et luberculeuse 013,0
Toutes les rubrlques, sauf rougeola 055, orelllons 072, poliomyellte 045, rubeole 056
el fievre jaune 060
Saul typho!de 002,0 et paratyphoids 002, 111002,9
Les codes de la CIM·9 figurant dans la liste ne sont peu\.81re pas pomplets, Quant aux codes a 5
chiffres, ils ne sont pas officials, ayanl ate etablis uniquement aux fins de la surveillance du LLCM •.
a
(
152
a
Notifiable Diseases Summary(Concluded)-Sommalre des maladies declaration obllgalolre(fin)
Month Ending February 28, 1991- Periode se termlnant le 28 fevrler
Disease
ICD-9
Ontario
Manttoba
Saskatchewan
Alberta
British Columbia
Yukon
Northwest Territories
Terrltolres du
Nord-Quest
Cum. Cum.' Cur. Cum. Cum.'
Cur. Cum. Cum.'9
91
91
90
Cou.
90 Cou.
91
0
Colomble-Br~annlque
Cur. Cum. Cum. Cur. Cum. Cum.' Cur. Cum. Cum.' Cur. Cum. Cum.' Cur.
Cou.
91
90 Cou.
91
91
90 Cou.
90 Cou.
91
90 Cou.
042-044
AIDS-Sida
006
Amoebiasis • Amibiase
64 153
Botulism· Botulisms
005.1
023
Brucellosis • Brucellose
008.41' 348 820
Campylobacteriosis • Campylobacteriose
099.0
Chancrold • Chancre mou
Chickenpox • Varicelle
052
Chlamydia, genital· Chlarnydiose genitals
099.01· 1139 2569
Cholera· Cholera
001
Diphtheria· Diphterie
032
Glardiasis • Giardiase
007.1 297 664
Gonocoocal Infections·
098 446 1114
Infections gonococciques
Gonocoocal Ophthalmia neonatorum •
098.4
Ophtalmle gonococcique du nouveau-ne
22
Haemophilus influenzae B (all invasive) • 320.0,038.41'
11
(invasive) a H. lnfluenzae B
070.0,070.1
43
90
Hepatttis A· Hepattte A
070.2,070.3 119 244
Hepatttls B • Hepattte B
Hepatitis C • Hepatite C
1
10
Hepatitis non·A, non·B •
Hepatlte non-A, non-B
Herpes Simplex (congenltaVneonatal) •
771.21·
- Herpes (congenttaVneonatal)
Legionellosis • Legionellose
482.81
5
11
Leprosy· Lepre
030
3
027.0,771.22·
Llsteriosis (all types) •
Listeriose (tous genres)
Malaria· Paludisme
084
22
45
055 148 370
Measles· Rougeofe
Meningitis, pneumocoocal •
320.1
4
Meninglte pneumocoques
Meningitis, other bacterial.
3
7
Autres menlngites bacteriennes
("
mingitis\Encephalttls viral·
9
.Aeningtte\encephalite virale
Meningococcal Infections·
039 12' 30
Infections meningocoques
Mumps· Oreillons
072
14;\ 21·
Paratyphoid· Paratyphoids
002.1-002.9
3
3
Pertussis· Coqueluche
033
171
6~
Plague· Pesta
020
- _,
Poliomyelitis· Poliomyeltte
045
Rabies ·Rage
071
Rubella· Rubeole
056
6
14
Congenltal Rubella-Rubeole congenitale
771.0
- Salmonellosis • Salmonellose
003 195 485
Shigellosis • Shigellose
004
56 117
. 091
Syphilis
28
58
Early, Symptomatic· Symptomatique,
recente
090,092-097
Other Syphilis • Autres syphilis
68 133
Tetanus· Tetanos
037
Trichinosis· Trichinose
124
Tuberculosis· Tuberculeuse
010-018
42
97
Typhoid· Typhiide
002.0
3
4
oos,01• 13 61
Verotoxigenfc E. coli· E. coli
verotoxinoglmes
.. , . 060
Yellow Fever· Fievre jaune
a
a
-
.,
SYMBOLS
Not reportable
Not available
No cases reported
-
-
137
-
..
2
1
2
3
6
-
-
-
4
7
16
15
-
-
-
-
-
-
-
-
-
-
-
-
8
30
63
123
-
-
-
550
-
-
-
-
..
-
25
7
14
-
17
30
-
755
756
330
-
-
-
-
-
-
-
-
-
-
3
-
-
-
227
57
72
122
128
120
140
104
121
229
242
-
-
-
-
-
-
-
364
..
..
83
177
-
-
-
-
1
1
5
-
-
1
5
5
15
6
11
6
16
4
64
10
41
7
-
-
-
-
-
-
-
-
-
-
1
-
-
-
-
-
-1
-
-
1
-
-
-
-1
-
3
2
1
..
..
..
..
..
..
..
-
-
-
1
1
69
87
-
-
-
-
-
-
...!.
-
-
-
134
126
231
127
190
-
-
313
-
-
-
-
-
-
-
-
328
..
769 1893 3017
-
-
56
87
-
-
-
59
31
19
-
106
-
-
-
-
-
299
244
4
8
6
11
3
10
2
16
6
15
4
92
-
-
-
-
-
-
-
-
-
-
-
9
13
2
-
-
-
-
1
4
33
5
73
21
60
18
18
63
37
106
126
136
-
-
-
-
-
-
-
8
-
-
-
-
·-
-
-
-
4
-
-
-
-
-
-
-
3
2
9
4
3
12
6
7
20
6
6
18
8
-
2
3
-
-
-
-
1
1
-
1
1
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
1
-
2
2
-
-
-
-
2
3
6
8
2
3
6
1
1
2
2
3
8
1
2
6
-
-
4
6
13
24
4
8
11
-
-
-
-
-
-
-
-
..
..
..
..
..
..
-
27
12
22
12
67
276
15
22
45
-
-
-
-
-
-
-
-
-
-
-
-
-
14
-
-
-
-
-
-
-
32
6
26
11
-
-
-
-
-
1
3
-
45
26
1
-
-
-
-
-
1
-
-
-
-
-
-
4
-
-
-
-
2
1
-
-
-
6
. Adeclaration non obligatoire
-
40
-
-
1
-
-
-
-
-
-
-
2
16
17
-
146
25
-
-9
53
11
1
-
-
-3
58
60
-
SIGNES
.. Non disponible
Aucun cas declares
-
-
-
-
-
-
-
7
11
-
-
155
36
2
1
134
21
3
-
-
-
-
2
-
-
-
-
-
-
-
-
-
-
-
-
-
-
5
19
-
-
-
1
-
-
-
-
3
-
-
-
-
-
-
-
-
-
SOURCE:
-
1
-
4
-
-
3
-
-
-
-
-
1
7
1
2
1
3
1
6
5
-
-
-
-
-
-
SOURCE:
Division of Biometrics
Laboratory Centre for Disease Control
Health and Welfare Canada
Ottawa, Ontario K1A OL2
Division de la Biometrie
Laboratoire de Jutte centre la malar
Santa et Bien~tre social du Canac
Ottawa{Ontario) K1A OL2
Tel.:(613)957-0334
Tel.:(613)957-0334
153
5
-
-2
-
-
-
-
5
2
-
21
-
2
-
-
-
-
-
-
2
-
86
25
1
29
1
-3
-
-
162
9
10
-
-
-
-
-
5
9
-
1
2
-
-
-
-
-
-
-
1
1
-
-
-
-
299
-
-
-
1
-
-
-
-
-
-
-
-
-
-
-
.1
-
-
-
-
-
-
-
1
-
1
4
-
1
-
-
4
-
-
10
2
-
-
-
3
-
-
-
117
-
1
-
-
159
118
-
-
98
-
240
247
4
4
-
48
-
-
-
-
-
-
-
-
-
-
-
1
273
223
..
..
..
..
-..
-
1
-
-
-
..
2
-
12
31
-
~
-
-
11
..
1
1
-
-
~-
._____,,
... /
Table 6 I Tableau 6
IDlstribuUon of all Citations of Immunizing Agent Temporally Associated with Adverse Event Reports by Nature of Adverse Event and by Vaccine Distribution, Canada, 1989
Repartition des signalements des effets secondalres relies dans le temps a des vacclns selon la nature de l'effet secondalre et le vaccin distribue (Canada 1989)
IMMUNIZING AGENT FREQUENCY (rate per 100,000 doses distributed)
AGENT IMMUNISANT FREQUENCE (taux ~our 100 000 doses distribues)
ADVERSE EVENT
EFFET SECONDAIRE
Adenopathy/Adenopathie
Allergic Reaction/Reaction allergique
Anaesthesia/Paresthesia
Anesthesie/paresthesie
Anaphylaxis/Anaphylaxie
Arthralgia/Arthritis/Arthralgie/arthrite
Convulsion/Seizure/Convulsion
Encephalopathy/Encephalopathie
Fever 39.0"C - 40.4'C
Fieme 39.o·c - 40.4'C
Fever:::: 40.5"C/Fievre:::: 40.5'C
Fever Not Recorded
Fievre non mesuree
10( 0.7)
71( 4.7)
2
13
6
58
DPT•
Other
ocT·
autre
2
0
0(
2(
7(
53(
0(
0.0)
0.1)
0.5)
3.5)
0.0)
0
1
2
16
0
0
1
4
36
0
0
0
1
1
0
594(39.1)
93( 6.1)
226
37
355
55
13 366(16.1)
1 56( 2.5)
203(13.4)
75
123
5 129( 5.7)
DPT Total DPT' Alone
OCT' seul
OCT total
DPT*/OPV
DCT*/Sabin
FLU
OPV
Sabin
DPTP
DCTP
7( 0.3)
65( 2.9)
0( 0.0)
11( 1.1)
2( 1.8) 2( 0.1)
7( 6.2) 15( 0.6)
2(
1{
6(
36(
0(
0(
2(
1(
19(
0(
0(
0(
1(
2(
0(
0.1)
0.1)
0.3)
1.6)
0.0)
0.0)
0.2)
0.1)
1.9)
0.0)
0.0)
0.0)
0.9)
1.8)
0.0)
4(
1(
3(
3(
0(
HIB/Hib IPV/Sask
1( 0.3)
9( 2.8)
0.2) 1( 0.3)
0.1) 3( 0.9)
0.1) 7( 2.2)
0.1) 11( 2.1)
0.0) 0( 0.0)
3( 0.6)
17( 3.1)
0(
0(
0(
0(
0(
0.0)
0.0)
0.0)
0.0)
0.0)
R RAB/Rab
MMRVac
ROR
TYPHITyph
Td
TdP
YF/Fj
1( 0.9)
1( 0.9)
10( 1.6)
17( 2.8)
3( 5.1)
5( 8.4)
0( 0.0)
4(38.9)
2( 1.9)
1( 0.9)
4( 0.5)
8( 1.0)
0( 0.0)
7( 1.2)
1( 1.3)
1( 1.3)
0(
0(
0(
0(
0(
0(
1(
7(
20(
0(
0.0)
0.2)
1.1)
3.3)
0.0)
1( 1.7)
0( 0.0)
8(13.5)
1{ 1.7)
0( 0.0)
0(
0(
1(
0(
0(
2(
0(
2(
0(
0(
3(
1(
5(
0(
0(
1(
1(
1(
0(
0(
0(
0(
0(
0(
0(
0.0)
0.0)
0.0)
0.0)
0.0)
0.0)
0.0)
9.7)
0.0)
0.0)
1.9)
0.0)
1.9)
0.0)
0.0)
0.4)
0.1)
0.6).
0.0)
0.0)
0.2)
0.2)
0.2)
0.0)
0.0)
0.0)
0.0)
0.0)
0.0)
0.0)
7( 0.3)
1( 0.1)
5( 1.5)
0( 0.0)
71(13.2)
18( 3.4)
2( 1.8)
0( 0.0)
57( 9.3)
13( 2.1)
1( 1.7)
0( 0.0)
0( 0.0)
0( 0.0)
3( 2.8)
0( 0.0)
2( 0.3)
0( 0.0)
3( 0.5)
1( 0.2)
0( 0.0)
0( 0.0)
8( 7.1) 12( 0.5)
8( 2.5)
27( 5.1)
0( 0.0)
20( 3.3)
2( 3.4)
0( 0.0)
4( 3.7)
5( 0.6)
2( 0.3)
0( 0.0) '<t
89( 8.9) 11 { 9.7)
13( 1.3) 1( 0.9)
39( 3.9)
HB
Flu
DT
I{)
.-
Guillain-Barre Syndrome
Syndrome de Guillain-Barr
Hypotonic-Hyporesponsive episode
Reaction d'hyp0tonie et
d'hypo reactivite
Infective Abscess/Abces infectieux
Meningitis and/or Encephalitis
Meningite et{ou) encephalite
Orchitis/Orchite
Other Events/Autres manifestations
Paralysis/Paralysie
Parotitis/Parotidite
Rashes/Eruption
Screaming Episode/Ciis
Severe Pain and/or Severe Swelling
Douleur intense et{ou) enflure grave
Severe Vomiting and/or Diarrhea
Vomissements graves et(ou) diarrhee
Sterile Abscess/Nodule/Necrosis
Abces sterile/nodule/necrose
Thrombocytopenia!Thrombocytopenie
All/Total
.
"
1( 0.1)
0( 0.0)
0( 0.0)
0( 0.0)
0( 0.0)
0( 0.0)
0( 0.0)
0( 0.0)
0( 0.0)
0( 0.0)
0( 0.0) 0( 0.0)
0( 0. 21,. 0( 0.0)
3( 0.9)
0( 0.0)
9( 1.7)
1( 0.2)
0( 0.0)
0( 0.0)
0( 0.0)
0( 0.0)
0( 0.0)
0( 0.0)
0( 0.0)
0( 0.0)
0( 0.0)
0( 0.0)
0( 0.0)
0( 0.0)
1( 0.2) 0( 0.0)
0( 0.0) ' 0( 0.0)
0( 0.0)
0( 0.0)
7( 0.7)
0( 0.0)
0( 0.0)
3( 0.3)
121 (12.1)
0( 0.0)
0{70.0)
0( 0.0)
o~ o.O) ~
o{ 9.9) _ o{ o.o)
0(
0(
4(
0(
0(
3(
0(
0( 0.0)
0( 0.0)
3(29.2)
0( 0.0)
0( 0.0)
0( 0.0)
0( 0.0)
0(
0(
5(
0(
0(
2(
0(
0(
0(
6(
0(
0(
4(
0(
0(
0(
3(
1(
0(
2(
0(
NA/ND**
10( 1.0)
8( 7.1)
1( 0.1)
5( 1.5)
3
60( 2.6)
19( 1.9)
3( 2.6)
6( 0.2) 14( 4.3)
0
0
NA/ND..
10( 1.0)
0( 0.0)
364
2( 1.8)
0( 0.0)
52
0( 0.0)
0( 0.0)
81
0( 0.0)
0
0
0
0( 0.0)
1( 0.1)
106( 7.0)
7( 0.5)
36
3
70
3
0
1
70( 3.1)
0( 0.0)
19( 1.9)
0( 0.0)
1( 0.1)
0( 0.0)
35( 2.3)
0( 0.0)
0( 0.0)
19( 1.3)
587(38.7)
0
0
11
0
0
5
224
1
0
24
0
0
13
360
0
1( 0.1)
0( 0.0)
0
0 27( 1.2)
2( 0.1)
0
0
0( 0.0)
1 14( 0.6)
3 360(15.8)
98( 6.5)
34
61
3
86( 5.7)
26
57
53( 3.5)
1( 0.1)
2026
32
0
743
21
1
1249
34
1( 0.1)
1203
0( 0.0)
.,.
2(
0(
0(
1(
4(
1.8) 2:3(0'.9) :33(10.2)
0.0) . 0( 0.0) 0( .O.O)
0.0) 0( 0.0) 0( 0.0)
0.9) 2( 0.1) 4( 1.2)
3.5) 0( 0.0) 0( 0.0)
0( 0.0)
0( 0.0)
104
0(
0(
11(
0(
0(
9(
13(
0.0)
0.0)
2.1)
0.0)
0.0)
1.7)
2.4)
0(
0(
1(
0(
0(
0(
1(
0.0)
0.0)
4.7)
0.0)
0.0)
1.9)
0.0)
0.0)
0.0)
0.7)
0.0)
0.0)
0.5)
0.0)
0.0)
0.0)
0.5)
0.2)
0.0)
0.3)
0.0)
0(
0(
3(
0(
0(
0(
0(
0.0)
0.0)
3.8)
0.0)
0.0)
0.0)
0.0)
0.0)
0.0)
0.9)
0.0)
0.0)
0.0)
0.9)
0( 0.0)
0( 0.0)
14( 2.3)
0( 0.0)
17( 2.8)
72(11.7)
2( 0.3)
15( 2.8)
0( 0.0)
2( 0.3)
0( 0.0)
1( 9.7)
3( 2.8) 15( 1.8)
3( 0.5)
0( 0.0)
14( 2.6)
0( 0.0)
8( 1.3)
0( 0.0)
0( 0.0)
3( 2.8)
1( 0.1)
1( 0.2)
1( 1.3)
3( 0.6)
0( 0.0)
211
1( 0.9)
0( 0.0)
7
1( 0.2)
2( 0.3)
263
0( 0.0)
0( 0.0)
28
0( 0.0)
0( 0.0)
9
2( 1.9)
0( 0.0)
29
3( 0.4)
0( 0.0)
57
0( 0.0)
0( 0.0)
27
0( 0.0)
0( 0.0)
6
For those figures broken down by antigen combinations administered with DPT, rates are not provided as the denominator is unknown}
Pour les chiffres correspondant aux combinaisons d'antigenes administrees avec le OCT, les taux ne son! pas fournis etant donne que le denominateur n'est pas connu.
Not available/Non disponible.
0.0)
0.0)
6.8)
0.0)
0.0)
5.1),
0.0);
0( 0.0)
contact with the health-care
system than those who are
younger. Adverse events
occurring in the older age groups
'llay be less likely to come to the
tention of health-care providers
... nd, thus, may be less likely to be
reported. The observation could
also reflect a genuine decrease in
the rate of reactions among
individuals who have been
previously immunized. The fact
that the pattern varies with the
type of reaction (for fever, there
is a fairly large decrease after the
third dose, whereas, for local
reactions, there are more reports
after the third dose) may help in
the interpretation.
OUTCOME
Table 7 I Tableau 7
Distribution of Citations of Immunizing Agent Temporally
Associated Adverse Event Reports for the Ten Most Frequent
Adverse Events, Canada, 1987·1989
Effets secondaires reliees dans le temps des agents
immunisants : repartition des declarations pour les dix effets
secondaires les plus frequents (Canada 1987-1989) ·
a
Frequency (rate/100,000 doses distribµted)
Frequence (taux/100 000 doses distribuees)
Adverse Event /Effets secondaires
Fever I Fievre
Screaming Episode I Cris
Allergic Reaction I Reaction allergique
Severe Pain and/or Severe Swelling
Douleur intense et (ou) oedeme important
Severe Vomiting and/or Diarrhea/
Vomissements graves et {ou) diarrhea
Other Severe or Unusual Events
Autres reactions graves OU inhabituelles
Hypotonic/HyporesponsiveEpisode
Episode <fhypotonie/hyporeactivite
Rashes I Eruption
Convulsion/Seizure/ Convulsion
Sterile Abscess/Nodule/Necrosis
Abces sterile/nodule/necrose
1987
1988
897(8.8)
453(4.4)
138(1.4)
1,366(12.8)
584(5.5)
151(1.4)
1,217(9.7)
720(5.7)
167(1.3)
97(0.9)
125(1.2)
149(1.2)
143(1.4)
115(1.1)
150(1.2)
existe peut-etre une diminution
veritable du taux de reactions chez les
individus qui ont deja ete immunises.
La repartition des signalements
d 'effets secondaires difrere selon le
type de reaction considere: on signale
significati vement mains de fievre mais
plus de reactions locales apres la
troisieme dose. On peut epiloguer
lil.-dessus.
1989
ISSUE
53(0.5)
75(0.7)
148(1.2)
Bien que dans nos formulaires de
Although ourreporting forms
request information on the
declaration nous demandions des
95(0.9)
96(0.9)
132(1.0)
outcome of adverse events, no
renseignements sur I 'issue des effets
87(0.9)
153(1.4)
114(0.9)
such data were available for 329
secondaires, nous ne possedons aucun
126(1.2)
142(1.3)
99(0.8)
patients (13.7%). Special effort
renseignement ace sujet pour 329
patients (13,7 %). Nous avons tente
was made to ascertain the
73(0.7)
73(0.7)
72(0.6)
outcome of the most severe
tout specialement de connaitre le sort.
Au moment
nous redigeons ce
adverse events. The distribution
rapport, 2 069 patients (86, 1 %) se
ofimmunizing agent-associated
adverse events by outcome at the
sont completement retablis, 5 (0,2 %)
Table 8 I Tableau 8
ont garde des sequelles. Un deces a ete
time of this report indicated that
Distribution of DPT/DPTP Temporally Associated Adverse Event
signale; il aurait fait suite a
2069 patients (86.1 % ) were fully
Reports by Dose Number, Canada, 1989
recovered and 5 patients (0.2%)
I' administration du vaccin antigrippal
Repartition des rapports d'effets secondaires relies dans le
a un homme de 93 ans souffrant de
still had residual effects. One
temps I' administration de vaccins DCT/DCTP selon l'ordre de la
dyspnee en rapport avec un oedeme
death was reported. The one
dose (Canada 1989)
pulmonaire. Le medecin qui signale le
death was reported following the
cas indigue qu'il pourraitexister un
use of influenza vaccine in a 93·
Dose Number
Frequency (Percent)
. year-old male who suffered
rapport de causalite entre
Ordre de la dose
Frequence(pourcentage)
l'adminisiration du vaccin etledeces
~spiratory distress with
All reactions
Fever
Severe local reactions
et qu 'il pourrait s 'agir d 'une reaction
,.u1monary edema. The reporting
Tou~s les reactions
Fievre
Reactions locales marquees
physician described the
allergique. Les sequelles comprennent
1
506 (26.9)
155 (15.0)
8
(7.3)
association between the vaccine
2 cas de poliomyelite paralytique
2
468 (28.0)
253 (24.5)
15 (13.8)
relies a I'administration du vaccin
administration and the death as
3
360 (19.6)
259 (25.1)
7 (6.4)
Jossible and also mentioned it
antipoliomyelitique buccal, un cas de
4
250 (12.7)
179 (17.4)
37 (33.9)
perte auditive attribue au vaccin
could have been an allergic
5
194 (7.8)
130 (12.6)
33 (30.3)
antigrippal, un cas de diminution de la
reaction. The cases with residual
Unknown/ lnconnu 104 (7.2)
55 (5.3)
9 (8.3)
sensibilite tactile des doigts
effects include 2 0 PY-related
TOTAL
1882 (100.0)
1031 (100.0)
109 (100.0)
consecutive a I' utilisation du vaccin
paralytic poliomyelitis cases, one
anti-hepatitique B et encore presente
loss of hearing attributed to
jusqu 'a uncertain point au !I\Oment de
influenza vaccine, one case of
la redaction du rapport mais au sujet de laquelle il n 'a pas ete possible d'obtenir
hypoesthesia in fingers following the use of the hepatitis B vaccine said
d'autres renseignments par la suite, et un cas Mnin et en voie de remission
to have limited residual effect at time of report but for which no further
d'arthralgie consecutif al' utilisation du ROR.
information could be obtained, and one case of mild arthralgia
following the use of the MMR vaccine that was improving.
ou
a
One hundred and eighty-nine patients were hospitalized for periods
ranging from 1 to 28 days (average duration 3.5 days). By far, the
leading causes for hospitalization were high fever and convulsions.
Cent quatre-vingt-neuf patients ont ete hospitalises pendant 1 a 28 jours
(duree moyenne d'hospitalisation: 3,5 jours). La fievre et les convulsions sont
de tres loin les principales causes d'hospitalisation signalees.
DISCUSSION
DISCUSSION
The major shortcomings of the vaccine-associated adverse event
reporting system are the following: (J) temporal reporting bias, (2)
underreporting, (3) lack of baseline rate and accurate denominator data,
and (4) attribution difficulty when multiple antigens or vaccines are
given simultaneously. These can artificially increase or decrease the
rate of adverse reactions and make it difficult to obtain a true estimate.
The frequent use of multiple antigens makes it difficult to evaluate the
causality of a relationship between a specific vaccine or vaccine
component and a specific medical outcome. Many are not caused by
any component but are accidental temporal coincidences.
Les principaux defauts du systeme de declaration des effets secondaires
relies a des agents immunisants sont: 1) le biais de declaration en fonction du
temps, 2) la sous-declaration, 3) I'absence de taux de reference et de
denominateurs precis, 4) la difficulte d 'attribution lorsque plusieurs antigenes
ont ete administres simultanement. Tous ces facteurs peuvent augmenter ou
diminuer de maniere factice les taux d 'effets secondaires et rendre difficiles !es
estimations exactes. L 'administration simultanee de plusieurs antigenes nuit a
l'etablissement d 'un lien causal entre un vaccin ou l 'une de ses composantes et
une issue medicale donnee. De nombreux cas representent sans doute des
coincidences et n 'ontrien a voir avec les composantes vaccinales.
The differences in results from 1987 through 1989 should be
interpreted with caution because (1) the system was started in 1988
lith retrospective classification of 1987 data, (2) the number of doses
-tlistributed is a proxy denominator, and (3).adjustments were made in
reporting. However, the trend toward a decrease in the rate of adverse
II faut interpreter les differences observees dans les resultats de 1987 a 1989
avec prudence. En effet, 1) le systeme a ete mis surpied en 1988 en utilisant une
classification retrospective des donnees de 1987, 2) le nombre de doses
administrees est un denominateut approximatif, 3) des modifications ont ete
apportees au systeme de declaration depuis son implantation. II convient
,,155
reactions reported following the use of the MMR vaccine between 1987
and 1988 was accentuated between 1988 and 1989.
toutefois de noter que la tendance ii la baisse du taux des declarations d 'effets
secondaires consecutifs iil'administration du ROR observee entre 1987et1988
s'est accentuee entre 1988et1989.
The number of adverse events reported for passive immunizing
agents probably greatly underestimates the true number of adverse
reactions because the administration of these agents occurs outside the
public health system, which is more involved in the reporting system
Les chiffres relatifs aux declarations d'effets secondaires relies aux agents
d 'immunisation passive representent probablement une sous-estimation
importante de leur nombre reel, clans la mesure oii l 'administration de ces agents
se fait en dehors du systeme de sante publique, qui se prete mieux ii la
declaration.
Provincial/territorial differences in rates of reported adverse events
emphasize the need to improve the sensitivity and timeliness of this
reporting system We request that all physicians and nurses who
administer vaccines participate actively in the reporting of any adverse
events temporally related with vaccine administration for the benefit of
the public and the health care system
Les differences qui existent entre les provinces et les territoires clans !es taux
de declaration d'effets secondaires fontressortir la necessite d'ameliorerla
sensibilite de ce systerne de declaration et de le mettre ii jour. Nous. invitons les .
medecins et les infirrnieres qui administrent les vaccins ii participer de fa~on
active au programme de declaration des effets secondaires relies clans le temps ii
des agents immunisants, pour le plus grand benefice du public et des services de
sante.
Although the focus of this report is vaccine-associated adverse
events, it is important to view the occurrence of such events in their
proper context Over 11 million doses of vaccine were distributed in
1989. Even if a large number of the doses were not administered and
. some severe events were not recognized or reported, the rate of
occurrence of such events appears to be very low. The morbidity and
mortality prevented by vaccination far outweighs this very low risk of
severe adverse events.
References
1. Koch J, Leet C, McCarthy R, Carter A. Adverse events
temporally a~so~iated with immunizing agents-1987 report.
/
!
\
Quand on parle des effets secondaires des agents immunisants, il est
important de les considerer clans leur contexte. Plus de 11 millions de doses de
vaccins ont ete distribuees en 1989. Meme si une part significative de ces doses
n 'a peut-etre pas ete administree, et meme sil'on admet que certaines
manifestations graves ont pu passer inaper~ues ou ne pas etre signalees, le taux
de survenue de ce genre de manifestations parait tres faible. La morbidite et la
mortalite prevenues par la vaccination excedent largement ce risque tres faible de
manifestations indesirables graves.
References
1. Koch J, Leet C, McCarthy R, Carter A. Manifestations facheuses
CDWR 1989,15.151-8.
2. Duclos P, McCarthy R, Koch J, Carter A. Adverse events
temporally associated with immunizing agents-1988 report.
CDWR 1990;16:157-66.
3. National Advisory Committe on Immunization. Canadian
immunization gmde. 3rd ed. Ottawa, Ont: Health and Welfare
Canada, 1989 (Supply and Services Canada, Cat. no.
H49-8/1989E).
associees dans le temps a des agents immunisants - Rapport de 1987.
RHMC 1989;15:151-8.
2. Duclos P, McCarthy R, Koch J, Carter A. Ejfets secondaires relies
dans./e t~mpsa des agents immunisants (annee 1988). RHMC
1990,16.157-66.
3. Comite consultatif national de I' immunisation. Guide canadien
d'immunisation, 3° ed. Ottawa, Ont.: Sante et Bien-etre social Canada,
1989 (Approvisionnements et Services Canada, n° du catalogue
H49-8/1989F).
Acknowledgements
Remerciements
We thank all provincial/territorial epidemiologists and other people
and organizations who provided the data presente,d in this !JPOrt.
Les auteurs remercient tous !es epidemiologistes provinciaux/territoriaux et
toutes les personnes et les organismes qui leur ont fourni les donnees presentees
clans ce rapport.
Source: Philippe Duclos, DVM, PhD, jo/m K.,Ot:;h, BSc, Myrna
Hardy, RN, Anne Carter,MD, Robert~McCarthy, RN,
Bureau of Communicable Disease Epiijemiology, Laboratory
Centre for Disease Control, Ottawa, Ontario.
Source: Philippe Duclos, DMV, PhD, John Koch, BSc, Myrna Hardy, IA,
Anne Carter, MD, Roberta McCarthy, IA, Bureau de!' epidemiologie
des maladies transmissibles, Laboratoire de lutte con/re la malad1e,
Ottawa (Ontario).
(
(
156
Annexe I
Appendix I
Code
Definitions Used For Reportable Adverse Events
Code
Definitions s'appliquant aux effets secondaires devant etre
declares
)1)
(02) &
(03)
(04)
Fever: Temperature greater than or equal to 40.5°C.
Fever: Temperature greater than or equal to 39.0°C and
less than or equal to 40.4°C.
Fever : Temperature not recorded but believed to be very
high and presence of other systemic symptoms.
Infective abscess at the site of immunization : One with a
positive Gram stain or culture.
Sterile abscess at the site of immunization : One in which
there was no evidence ofmicrobiologic infection.
Nodule at the site of immunization: One which persists for
more than a month and is larger than 2.5 cm in diameter
and/or one in which drainage is evident.
Necrosis at the site of immunization: Presence of
morphologic changes indicative of cell death and caused
by the progressive degradative action of enzymes is
evident.
Severe local pain at the site of immunization : Pain which
lasts for at least 4 days or requires hospitalization.
Severe swelling at the site of immunization : Swelling
which extends past the nearest joint (as in arm past elbow).
(01)
(02) et
(03)
(04)
Fievre: Temperature d'au moins 40,5°C.
Fievre: Temperature d'au moins 39,0°C et d'au plus
40,4°C.
Fievre: Ter..perature non enregistree, mais qu' on croit tres elevee,
et presence d'autres symptomes generaux.
Abces infectieux au point d' inoculation : resultat positif du Gram
ou de la culture.
'
Abces sterile au point d' inoculation : nul signe d'infection
microbienne.
Nodule au point d'inoculation: persistant plus d'un mois et d'un
diametre de plus de 2,5 cm OU presentant Un ecoulement.
Necrose au point d' inoculation: sign es morphologiques de necrose
cellulaire evoquant une degenerescence d'origine eilzymatique.
(05)
(06)
(07)
(08)
(09)
(10)
(11)
(12)
I
\
{12)
(13)
(14)
(15)
(16)
(17)
(18)
(19)
(20)
(21)
(22)
(23)
(24)
1](25)
(26)
Adenopathy : Severe (or unusual) enlargement or drainage
of the lymphatic nodes.
Allergic Reaction: One in which there is evidence of
hives, wheezing, puffiness or generalized edema.
Rashes : Those that are severe (i.e. last at least 4 days or
require hospitalization).
Anaphylaxis : An event characterized by swelling of
mouth/throat, difficulty breathing, shock, cardiovascular or
respiratory collapse.
Hypotonic-Hyporesponsive : One in which there is
evidence of Episode decrease/loss of muscle tone, pallor
or cyanosis, decreased level or loss of c;onsciousness, or
cardiovascular/respiratory arrest.
"
.
Excessive Somnolence : An event char~cterize4!by
prolonged sleeping with difficulty arousing. ·
ArthralgiaJArthritis: Joint pain whicht·lasts.at least 24
hours.
'·
Severe Vomiting and/or Diarrhea: ThjS event must
interfere with the patient's daily routine.
Screaming Episode : One in which the child.is
unconsolable and lasts at least 3 hours or in which the
quality of cry is definitely abnormal for the child and not
previously heard by the parents.
Convulsion/Seizure: One that involves muscle
contractions and decreased level of consciousness (may or
may not be associated with fever).
Encephalopathy : Diagnosis must be made by a physician.
Meningitis and/or Encephalitis : Diagnosis must be made
by a physician.
Anaesthesia!Paresthesia: Lasts over 24 hours.
Paralysis: Diagnosis must be made by a physician.
Guillain-Barre Syndrome : Diagnosis must be made by a
physician.
Subacute Sclerosing Panencephalitis: Diagnosis must be
made by a physician.
Parotitis: Swelling and/or tenderness of the parotid
gland(s).
Orchitis : Swelling with pain and/or tenderness of the
testicle(s).
Thrombocytopenia: Diagnosis must-be made by a
physician.
Other Severe or : Those that do not fit into any of the
categories Unusual Events listed above but were of
medical/epidemiologic interest and required medical
intervention.
(05)
(06)
(07)
(08)
(09)
(10)
(11)
(12)
Douleur intense au point d' inoculation : persistant pendant au
moins 4 jours OU necessitant !'hospitalisation.
Oedeme important au point d'inoculation: s'etendant au-dela de
I' articulation la plus proche (p. ex. enflure du membre superieur
allantplus bas que le coude).
Adenopathie: tumefactiort marquee (ou inhabituelle) ou
ecoulement des ganglions lymphatiques.
Reaction allergique: presence d'une urticaire, d'une respiration
sjfflante evoquant l' asthme, d 'un oedeme localise ou generalise.
Eruption: marquee (durant au moins 4 jours ou necessitant
I 'hospitalisation).
Anaphylaxie : reaction caracterisee par un oedeme de la bouche ou
de la gorge, une dyspnee, un etat de choc, un collapsus
cardiovasculaire ou respiratoire.
Reaction d' hypotonie et d' hyporeactivite : diminution ou perte du
tonus musculaire, paleur ou cyanose, diminution ou perte de
conscience ou arret cardiovasculaire ou respiratoire.
(12)
Somnolence excessive : sommeil prolonge avec difficulte de reveil.
(13)
Arthralgie ou arthrite: douleur articulaire d'une duree d'au moins
24 heures.
Vomissements graves, diarrhee ou les deux: assez graves pour
nuire aux occupations quotidiennes.
Cris: episode d'une duree d' au moins 3 heures pendant lequel
l' enfant est inconsolable ou dans lequel Jes pleurs sont
manifestement anormaux, ses parents ne l'ayantjamais entendu
pleurer de cette fai;:on.
Convulsion : contractions tonico-cloniques et perte plus ou moins
complete de conscience (avec ou sans fievre).
(14)
(15)
(16)
(17)
(18)
(19)
(20)
(21)
(22)
(23)
(24)
(25)
(26)
157
Encephalopathie : le diagnostic doit en etre pose par un medecin.
Meningite OU encephalite : le diagnostic doit en etre pose par un
medecin.
Anest/zesie OU parest/zesie : d 'une duree superieure a 24 heures.
Paralysie: le diagnostic doit en etre pose par un medecin.
Syndrome de Guillain-Barre : le diagnostic doit en etre pose par un
medecin.
Panencephalite sclerosante subaigue de Dawson-van Bogaert: le
diagnostic doit en etre pose par un medecin.
Parotidite: fluxion avec ou sans douleur a Ia pression dans la
region d'une OU des glandes parotides.
Orchite: fluxion douloureuse d'un ou des deux testicules avec
douleur Spontanee OU a Ja pression.
Thrombocytopenie : le diagnostic doit en etre pose par un medecin.
Autres manifestations graves ou rares : ne correspondant a aucune
des categories susmentionnees, mais presentant un interet d'ordre
medical OU epidemioJogique.
Annexe II
Appendix II
Temporal Criteria for Inclusion of Adverse Events
Criteres en fonction du temps pour l'inclusion des effets secondaires
The time from vaccine administration to onset of symptoms must be
within the time frame listed below for each kind of adverse event.
L 'intervalle entre l 'administration du vaccin et l 'installation des symptOmes
doit se situer dans les delais indiques au tableau qui suit pour chaque type d'effet
secondaire.
Adverse Event Code(s)*/Code(s)* des effets secondaires
Immunizing Agent
Agent immunisant
13
14
<24h
<72h 5-30d/j
5-30d/j
<7d/j
<24h
<72h
<72h
<72h
<7d/j
<24h
<72h
< 7d/j
18-19
20
21
22
23-24
5-30d/j
5-30d/j
5-30d/j
< 3ld/j
n/a/s/o
5-30d/j < 3ld/j
< 72h
< 7d/j
< 15d/j
< 15d/j
< 31d/j
n/a/s/o
n/a/s/o < 31d/j
< 15d/j
< 15d/j
< 15d/j
< 15d/j
< 3ld/j
n/a/s/o
n/a/s/o < 3ld/j
1-4
5-6
7
8
9
10
11
5-30d/j
n/a/s/o
<48 h
5-30d/j
<72h
5-30d/j
DPT/DPTP/DCT/DCTP
<72h
n/a/s/o
<48 h
< 7d/j
<72h
OTHER**/AUTRE**
<72h
n/a/s/o
<48 h
15
16
17
MMRVac/ROR
<72h
5-30d/j
DPT/DPTP /DCT/DCTP
<72h
OTHER** I AUTRE**
<72h
MMRVac/ROR
Immunizing Agent
Agent immunisant
12
25
26
Legend I Legende
d
days
h
hours
j
h
,.
,!,
n/a
not applicable
*
as defined in Appendix I
applies only to non OPV-related events. For OPV-related
events, the time interval is 4-60 days. For influenza-related
events, there is no time restriction.
s/o
sans objet
*
tel que defini al' Annexe I
ne s'applique pas aux manifestations reliees au vaccin
antipoliomyelitique buccal; pour celles-ci l'intervalle est
de 4 a 60 jours. Pour les manifestations liees au vaccin
antigrippal, il n'y a aucune restriction de temps.
**
Tous les cas de mort subite du nourrisson ont ete exclus:
on a pris pour acquis qu'ils n'etaient pas lies a
l' administration de vaccins conformement a des articles
deja publies.
All sudden infant death syndromes were excluded as deemed
umelated to vaccine administration according to previously
published papers.
1be Canada Dise~s Weekly Report presents current information on infectious and other diseases
for surveillance pwposes and is available free of charge upon icqucst. Many of the articles contain
preliminary information ancl further confirmation may be: obtained from the sources quoted. The
Department of Health and Welfiuc does not assume responsibility for accuracy or authenticity.
Contribution.! arc welcomed (in the official language ofyourcboioe) from anyone working in the
health field and will not preclude publication elsewhere.
Scientific Advi!ory Board:
Dr.J. Spika
Dr. K.Razee
Editor:
Assistant Editor.
Desktop Publishing:
Circulation:
FJcanot Paulson
Nicole Beaudoin
Joanno Regnier
Gertrude Tardiff
Bwcau of Communicable Disease Epidemiology
Laboratory Centre for Di!e= Control
Tunney 's Pasture
OTTAWA. Ontario
Canada
K!AOL2
(
non defini
undefined
**
jours
heures
(613) 957-4243
(613) 957-1329
(613) 957-1788
(613) 957-0841
(613) 957-7845
(613) 957-0842
Le Rapport hdxlomadaire des maladies au 6mada, qui foumit des donn6es pertinent.cs sur les maladies
infcctieuscs et les autrcs maladies dans le but de faciliter leur surveillance, peutCtre obtenu gratuitcment sur
demande. Un grand nombrc d 'articks ne conticnn:nt que des d~s sommaites mais des rcnseigncments
comptementaircs peuventCtre obtcntll en s'adJessant aux sources citees. Le ministrc de la SantC nationalc ct
du Bien..etre social ne peutCtrexcsponsable del'exactitude, ni de l'authenticitC des articles. Toute persoone
oeuvrant dam le domaine de la santC est invit6e 8. collaborer (dan,., la langue officic:Ue de son choix) et la
publication d'un article daru le present Rapport n'cn cmpCchc pas la publication ailleurs.
Groupe de conseillen scicntifiques:
D' J. Spika
(613) 957-4243
RCdactrice en chef:
RCdactricc adjointe:
Editique:
Distribution:
D'K. Rozee
Eleanor Paulson
Nicole Beaudoin
Joanne Regnier
Gertrude Tardiff
Bun: au d 'Cpidemiologie des maladies trammissiblcs
Laboratoire de lutte contre la maladie
Pli Tunney
OITAWA (Ontario)
Canada
K!AOL2
"158
(613) 957-1329
(613) 957-1788
(613) 957-0841
(613) 957-7845
(613) 957-0842
Was this manual useful for you? yes no
Thank you for your participation!

* Your assessment is very important for improving the work of artificial intelligence, which forms the content of this project

Download PDF

advertising