{"id":1487,"date":"2021-01-15T21:31:07","date_gmt":"2021-01-15T20:31:07","guid":{"rendered":"https:\/\/www.service-public.pf\/arass\/?page_id=1487"},"modified":"2024-08-08T15:32:25","modified_gmt":"2024-08-09T01:32:25","slug":"pharmacovigilance-des-vaccins-contre-la-covid-19","status":"publish","type":"page","link":"https:\/\/www.service-public.pf\/arass\/pharmacovigilance-des-vaccins-contre-la-covid-19\/","title":{"rendered":"D\u00e9clarer un effet ind\u00e9sirable d&rsquo;un vaccin contre la covid-19"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1216.8px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p style=\"text-align: justify\"><span style=\"font-size: 14pt;color: #000000\">Dans le cadre de la campagne de vaccination contre le Covid-19, un dispositif sp\u00e9cifique de surveillance renforc\u00e9e de l\u2019efficacit\u00e9 et des effets ind\u00e9sirables des vaccins anti-Covid-19 a \u00e9t\u00e9 mis en place. Ce dispositif s\u2019int\u00e8gre dans le <a style=\"color: #000000\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/overview\/public-health-threats\/coronavirus-disease-covid-19\/treatments-vaccines\/covid-19-vaccines-development-evaluation-approval-monitoring\" target=\"_blank\" rel=\"noopener\">plan de gestion des risques<\/a> coordonn\u00e9 par l\u2019Agence europ\u00e9enne du m\u00e9dicament (EMA). <\/span><\/p>\n<\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-color:rgba(255,255,255,0.68);--awb-bg-color-hover:rgba(255,255,255,0.68);--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5.76%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5.76%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div style=\"text-align:center;\"><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-1 fusion-button-default-span fusion-has-button-gradient\" style=\"--button_bevel_color:#c787ed;--button_accent_color:#c787ed;--button_border_color:#c787ed;--button_accent_hover_color:#7a7a7a;--button_border_hover_color:#c787ed;--button_border_width-top:1px;--button_border_width-right:1px;--button_border_width-bottom:1px;--button_border_width-left:1px;--button_gradient_top_color:rgba(242,242,242,0.74);--button_gradient_bottom_color:rgba(252,252,252,0.74);--button_gradient_top_color_hover:rgba(252,252,252,0.74);--button_gradient_bottom_color_hover:rgba(242,242,242,0.74);--button_margin-bottom:20px;\" target=\"_self\" href=\"https:\/\/www.service-public.pf\/arass\/patients\/\"><span class=\"fusion-button-text\">Je suis patient<\/span><\/a><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"align-self: center;margin-left: auto;margin-right: auto;width:100%;\"><\/div><div style=\"text-align:center;\"><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-2 fusion-button-default-span fusion-has-button-gradient\" style=\"--button_bevel_color:#6027a5;--button_accent_color:#6027a5;--button_border_color:#6027a5;--button_accent_hover_color:#7a7a7a;--button_border_hover_color:#6027a5;--button_border_width-top:1px;--button_border_width-right:1px;--button_border_width-bottom:1px;--button_border_width-left:1px;--button_gradient_top_color:rgba(242,242,242,0.74);--button_gradient_bottom_color:rgba(249,249,249,0.74);--button_gradient_top_color_hover:rgba(249,249,249,0.74);--button_gradient_bottom_color_hover:rgba(242,242,242,0.74);\" target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/www.service-public.pf\/arass\/professionnels-de-sante\/\"><span class=\"fusion-button-text\">Je suis professionnel de sant\u00e9<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-2 fusion_builder_column_2_3 2_3 fusion-flex-column\" style=\"--awb-padding-top:20px;--awb-bg-size:cover;--awb-width-large:66.666666666667%;--awb-margin-top-large:0px;--awb-spacing-right-large:2.88%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:2.88%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-alert alert custom alert-custom fusion-alert-left awb-alert-native-link-color\" style=\"--awb-background-color:var(--awb-color2);--awb-accent-color:#4b2c68;--awb-border-top-left-radius:0px;--awb-border-top-right-radius:0px;--awb-border-bottom-left-radius:0px;--awb-border-bottom-right-radius:0px;\" role=\"alert\"><div class=\"fusion-alert-content-wrapper\"><span class=\"fusion-alert-content\"><p><span style=\"font-family: georgia, palatino, serif;font-size: 14pt\"><span style=\"text-decoration: underline\">Pourquoi d\u00e9clarer les effets ind\u00e9sirables<\/span> ? <\/span><\/p>\n<p><span style=\"font-family: georgia, palatino, serif;font-size: 14pt\">Qu&rsquo;ils soient graves ou inattendus, les effets ind\u00e9sirables doivent \u00eatre d\u00e9clar\u00e9s imm\u00e9diatement afin de faire remonter le plus t\u00f4t possible des signaux et alerter les autorit\u00e9s de sant\u00e9.<\/span><\/p>\n<p><span style=\"font-family: georgia, palatino, serif;font-size: 14pt\">En d\u00e9clarant les effets ind\u00e9sirables qui ne sont pas encore connus :<\/span><\/p>\n<ul>\n<li><span style=\"font-family: georgia, palatino, serif;font-size: 14pt\">vous contribuez \u00e0 renforcer les connaissances sur les effets ind\u00e9sirable du vaccin<br \/>\n<\/span><\/li>\n<li><span style=\"font-family: georgia, palatino, serif;font-size: 14pt\">vous permettez aux autorit\u00e9s de sant\u00e9 de prendre au plus t\u00f4t les mesures de r\u00e9duction du risque n\u00e9cessaires.<\/span><\/li>\n<\/ul><\/span><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-3 fusion_builder_column_1_2 1_2 fusion-flex-column\" style=\"--awb-padding-top:20px;--awb-bg-size:cover;--awb-width-large:50%;--awb-margin-top-large:0px;--awb-spacing-right-large:3.84%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:3.84%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-alert alert custom alert-custom fusion-alert-left awb-alert-native-link-color\" style=\"--awb-background-color:var(--awb-color2);--awb-accent-color:#4b2c68;--awb-border-top-left-radius:0px;--awb-border-top-right-radius:0px;--awb-border-bottom-left-radius:0px;--awb-border-bottom-right-radius:0px;\" role=\"alert\"><div class=\"fusion-alert-content-wrapper\"><span class=\"fusion-alert-content\"><p style=\"text-align: center\"><span style=\"font-family: georgia, palatino, serif;font-size: 14pt;color: #4b2c68\"><strong><u>Que d\u00e9clarer\u00a0?<\/u><\/strong><\/span><\/p>\n<p><span style=\"font-family: georgia, palatino, serif;color: #4b2c68;font-size: 14pt\">Il vous est demand\u00e9 de d\u00e9clarer en priorit\u00e9, les <strong>effets ind\u00e9sirables graves et\/ou inattendus<\/strong> pour lesquels un lien de causalit\u00e9 est suspect\u00e9 avec la vaccination.<\/span><\/p>\n<p><span style=\"font-family: georgia, palatino, serif;color: #4b2c68;font-size: 14pt\">Un <strong>effet ind\u00e9sirable grave <\/strong>est un effet qui peut\u00a0:<\/span><\/p>\n<ul>\n<li><span style=\"font-family: georgia, palatino, serif;color: #4b2c68;font-size: 14pt\">Entrainer le d\u00e9c\u00e8s<\/span><\/li>\n<li><span style=\"font-family: georgia, palatino, serif;color: #4b2c68;font-size: 14pt\">N\u00e9cessiter une hospitalisation ou une prolongation d\u2019hospitalisation,<\/span><\/li>\n<li><span style=\"font-family: georgia, palatino, serif;color: #4b2c68;font-size: 14pt\">Mettre en jeu le pronostic vital.<\/span><\/li>\n<li><span style=\"font-family: georgia, palatino, serif;color: #4b2c68;font-size: 14pt\">Entrainer une incapacit\u00e9 persistante ou importante,<\/span><\/li>\n<li><span style=\"font-family: georgia, palatino, serif;color: #4b2c68;font-size: 14pt\">\u00catre responsable d\u2019anomalie ou de malformation cong\u00e9nitale (exposition <em>in utero<\/em>).<\/span><\/li>\n<\/ul>\n<p><span style=\"font-family: georgia, palatino, serif;color: #4b2c68;font-size: 14pt\">Si un patient a d\u00fb consulter son m\u00e9decin ou se rendre aux urgences \u00e0 cause de l\u2019effet ind\u00e9sirable pr\u00e9sent\u00e9, il est aussi pertinent de le d\u00e9clarer.<\/span><\/p>\n<p><span style=\"font-family: georgia, palatino, serif;color: #4b2c68;font-size: 14pt\">Un <strong>effet ind\u00e9sirable inattendu<\/strong> est un effet qui n\u2019est pas encore connu avec le vaccin et qui ne figure donc pas dans la notice du m\u00e9dicament. Cela peut \u00eatre l\u2019effet en lui-m\u00eame, mais aussi sa gravit\u00e9 ou sa fr\u00e9quence.<\/span><\/p>\n<p><span style=\"font-family: georgia, palatino, serif;color: #4b2c68;font-size: 14pt\">Les erreurs m\u00e9dicamenteuses, avec ou sans effet ind\u00e9sirables, et les risques d\u2019erreur m\u00e9dicamenteuse doivent \u00e9galement \u00eatre d\u00e9clar\u00e9es.<\/span><\/p><\/span><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-4 fusion_builder_column_1_2 1_2 fusion-flex-column\" style=\"--awb-padding-top:20px;--awb-bg-size:cover;--awb-width-large:50%;--awb-margin-top-large:0px;--awb-spacing-right-large:3.84%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:3.84%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-2\"><p style=\"text-align: center\"><span style=\"font-size: 14pt;font-family: georgia, palatino, serif\"><strong><span style=\"color: #4b2c68\"><u>Comment remplir le formulaire\u00a0de d\u00e9claration ?<\/u><\/span><\/strong><\/span><\/p>\n<p><span style=\"color: #4b2c68;font-family: georgia, palatino, serif;font-size: 14pt\">Avant tout, rassemblez tous les documents m\u00e9dicaux en relation avec l\u2019effet ind\u00e9sirable que vous allez d\u00e9clarer (certificat de vaccination, ordonnances, comptes rendus m\u00e9dicaux, r\u00e9sultats de laboratoire, etc).<\/span><\/p>\n<p><span style=\"color: #4b2c68;font-family: georgia, palatino, serif;font-size: 14pt\">Il est important que la d\u00e9claration soit la plus claire et la plus compl\u00e8te possible pour qu\u2019elle soit exploitable et puisse apporter\u00a0des informations pertinentes pour l\u2019\u00e9valuation de la s\u00e9curit\u00e9 du vaccin. Tous les champs du formulaire marqu\u00e9s d\u2019un ast\u00e9risque sont obligatoires. Ce sont les \u00e9l\u00e9ments indispensables \u00e0 l\u2019analyse votre d\u00e9claration.<\/span><\/p>\n<p><span style=\"color: #4b2c68;font-family: georgia, palatino, serif;font-size: 14pt\">Ainsi il est n\u00e9cessaire de mentionner\u00a0:<\/span><\/p>\n<ul>\n<li><span style=\"color: #4b2c68;font-family: georgia, palatino, serif;font-size: 14pt\">le nom du vaccin<\/span><\/li>\n<li><span style=\"color: #4b2c68;font-family: georgia, palatino, serif;font-size: 14pt\">le n\u00b0 de lot du vaccin<\/span><\/li>\n<li><span style=\"color: #4b2c68;font-family: georgia, palatino, serif;font-size: 14pt\">la date de vaccination<\/span><\/li>\n<li><span style=\"color: #4b2c68;font-family: georgia, palatino, serif;font-size: 14pt\">le rang vaccinal (1\u00e8re dose ou 2\u00e8me dose vaccinale)<\/span><\/li>\n<li><span style=\"color: #4b2c68;font-family: georgia, palatino, serif;font-size: 14pt\">le site de vaccination (bras droit ou gauche)<\/span><\/li>\n<li><span style=\"color: #4b2c68;font-family: georgia, palatino, serif;font-size: 14pt\">les effets ind\u00e9sirables constat\u00e9s, en \u00e9tant le plus pr\u00e9cis possible avec date de d\u00e9but, date de fin ou en cours (si un avis m\u00e9dical a eu lieu, il est important de mentionner le diagnostic retenu par le m\u00e9decin)<\/span><\/li>\n<li><span style=\"color: #4b2c68;font-family: georgia, palatino, serif;font-size: 14pt\">la date de survenue de ces effets ou le d\u00e9lai de survenue par rapport \u00e0 la vaccination<\/span><\/li>\n<li><span style=\"color: #4b2c68;font-family: georgia, palatino, serif;font-size: 14pt\">leur \u00e9volution (et leur prise en charge \u00e9ventuelle)<\/span><\/li>\n<li><span style=\"color: #4b2c68;font-family: georgia, palatino, serif;font-size: 14pt\">les ant\u00e9c\u00e9dents principaux de la personne vaccin\u00e9e (ex\u00a0: allergies connues, maladies chroniques, comorbidit\u00e9s, facteurs de risques \u00e9ventuels exposant \u00e0 une forme grave COVID-19 \u2026) et les traitements pris au moment de la survenue de l\u2019effet ind\u00e9sirable<\/span><\/li>\n<li><span style=\"color: #4b2c68;font-family: georgia, palatino, serif;font-size: 14pt\">tout compte rendu m\u00e9dical ou d\u2019hospitalisation pourra \u00eatre joint \u00e0 la d\u00e9claration si disponible<\/span><\/li>\n<\/ul>\n<p><span style=\"color: #4b2c68;font-family: georgia, palatino, serif;font-size: 14pt\">Pour en savoir plus, <a style=\"color: #4b2c68\" href=\"https:\/\/www.service-public.pf\/arass\/wp-content\/uploads\/sites\/46\/2021\/01\/2021-01-15-PV-Aide-mini.pdf\"><em>consulter l&rsquo;aide au remplissage<\/em><\/a><\/span><\/p>\n<\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-5 fusion_builder_column_3_4 3_4 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:75%;--awb-margin-top-large:0px;--awb-spacing-right-large:2.56%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:2.56%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-1 fusion-sep-none fusion-title-text fusion-title-size-six fusion-animated\" data-animationType=\"flash\" data-animationDuration=\"4.0\" data-animationOffset=\"top-into-view\"><h6 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:Tahoma,Geneva, sans-serif;font-style:normal;font-weight:400;margin:0;--fontSize:13;--minFontSize:13;line-height:1.5;\"><h1 style=\"text-align: left\"><span style=\"font-size: 24pt;color: #4b2c68\">Bon \u00e0 savoir<\/span><\/h1><\/h6><\/div><div class=\"accordian fusion-accordian\" style=\"--awb-border-size:1px;--awb-icon-size:15px;--awb-content-font-size:16px;--awb-icon-alignment:left;--awb-hover-color:var(--awb-color3);--awb-border-color:hsla(var(--awb-color8-h),var(--awb-color8-s),calc( var(--awb-color8-l) + 69% ),var(--awb-color8-a));--awb-background-color:var(--awb-color1);--awb-divider-color:var(--awb-color3);--awb-divider-hover-color:var(--awb-color3);--awb-icon-color:var(--awb-color1);--awb-title-color:#333333;--awb-content-color:#747474;--awb-icon-box-color:#4b2c68;--awb-toggle-hover-accent-color:#3f3f3f;--awb-title-font-family:&quot;Roboto Slab&quot;;--awb-title-font-weight:700;--awb-title-font-style:normal;--awb-title-font-size:20px;--awb-content-font-family:&quot;Roboto Slab&quot;;--awb-content-font-style:normal;--awb-content-font-weight:300;\"><div class=\"panel-group fusion-toggle-icon-boxed\" id=\"accordion-1487-1\"><div class=\"fusion-panel panel-default panel-b2cbf438640f219f0 fusion-toggle-has-divider\"><div class=\"panel-heading\"><h4 class=\"panel-title toggle\" id=\"toggle_b2cbf438640f219f0\"><a aria-expanded=\"false\" aria-controls=\"b2cbf438640f219f0\" role=\"button\" data-toggle=\"collapse\" data-parent=\"#accordion-1487-1\" data-target=\"#b2cbf438640f219f0\" href=\"#b2cbf438640f219f0\"><span class=\"fusion-toggle-icon-wrapper\" aria-hidden=\"true\"><i class=\"fa-fusion-box active-icon awb-icon-minus\" aria-hidden=\"true\"><\/i><i class=\"fa-fusion-box inactive-icon awb-icon-plus\" aria-hidden=\"true\"><\/i><\/span><span class=\"fusion-toggle-heading\">Qu'est ce que la pharmacovigilance ?<\/span><\/a><\/h4><\/div><div id=\"b2cbf438640f219f0\" class=\"panel-collapse collapse \" aria-labelledby=\"toggle_b2cbf438640f219f0\"><div class=\"panel-body toggle-content fusion-clearfix\">\n<p><span style=\"color: #4b2c68;font-size: 14pt\">Au cours du d\u00e9veloppement clinique de ces vaccins, comme pour tout m\u00e9dicament, les \u00e9v\u00e8nements et effets ind\u00e9sirables sont syst\u00e9matiquement enregistr\u00e9s par la firme pharmaceutique. Compte tenu du relativement faible nombre de personnes incluses dans les essais cliniques et de la dur\u00e9e courte du suivi, seuls les effets les plus fr\u00e9quents et de survenue pr\u00e9coce \u00a0sont susceptibles d\u2019\u00eatre d\u00e9tect\u00e9s (par exemple, si l\u2019\u00e9tude a inclus 10\u00a0000 personnes, un effet qui surviendrait chez 1 patient sur 100\u00a0000 n\u2019a que tr\u00e8s peu de chance de survenir).<\/span><\/p>\n<p><span style=\"color: #4b2c68;font-size: 14pt\">Une fois mis sur le march\u00e9, les m\u00e9dicaments (dont les vaccins contre la COVID-19), seront administr\u00e9s \u00e0 un nombre beaucoup plus important de personnes. Il est donc tr\u00e8s important de pouvoir continuer de suivre leurs effets ind\u00e9sirables potentiels. C\u2019est le principe de la pharmacovigilance.<\/span><\/p>\n<p><span style=\"color: #4b2c68;font-size: 14pt\">L\u2019objectif de la pharmacovigilance est de d\u00e9tecter des effets nouveaux et\/ou graves qui peuvent \u00eatre des signaux de s\u00e9curit\u00e9, non identifi\u00e9s dans les essais cliniques.<\/span><\/p>\n<p><span style=\"color: #4b2c68;font-size: 14pt\">Cette d\u00e9tection doit se faire en temps r\u00e9el et s\u2019appuie sur le principe de la <strong>notification spontan\u00e9e des effets ind\u00e9sirables par les acteurs du syst\u00e8me de soins, professionnels de sant\u00e9 et patients.<\/strong><\/span><\/p>\n<p><a href=\"https:\/\/www.service-public.pf\/arass\/wp-content\/uploads\/sites\/46\/2021\/01\/2021-01-12-Guide-PSL_PV_revALV.pdf\"><em><span style=\"color: #4b2c68;font-size: 14pt\">Pour en savoir plus sur la pharmacovigilance<\/span><\/em><\/a><\/p>\n<\/div><\/div><\/div><div class=\"fusion-panel panel-default panel-35f625959eefcf5e3 fusion-toggle-has-divider\"><div class=\"panel-heading\"><h4 class=\"panel-title toggle\" id=\"toggle_35f625959eefcf5e3\"><a aria-expanded=\"false\" aria-controls=\"35f625959eefcf5e3\" role=\"button\" data-toggle=\"collapse\" data-parent=\"#accordion-1487-1\" data-target=\"#35f625959eefcf5e3\" href=\"#35f625959eefcf5e3\"><span class=\"fusion-toggle-icon-wrapper\" aria-hidden=\"true\"><i class=\"fa-fusion-box active-icon awb-icon-minus\" aria-hidden=\"true\"><\/i><i class=\"fa-fusion-box inactive-icon awb-icon-plus\" aria-hidden=\"true\"><\/i><\/span><span class=\"fusion-toggle-heading\">Que deviennent les d\u00e9clarations ?<\/span><\/a><\/h4><\/div><div id=\"35f625959eefcf5e3\" class=\"panel-collapse collapse \" aria-labelledby=\"toggle_35f625959eefcf5e3\"><div class=\"panel-body toggle-content fusion-clearfix\">\n<p><span style=\"font-size: 14pt;color: #4b2c68\">La d\u00e9claration est prise en charge par un professionnel de sant\u00e9 de l\u2019ARASS, qui pourra \u00eatre amen\u00e9 \u00e0 vous recontacter si n\u00e9cessaire pour obtenir des informations compl\u00e9mentaires dans le respect du secret m\u00e9dical et professionnel.<\/span><\/p>\n<p><span style=\"font-size: 14pt;color: #4b2c68\">Toutes les d\u00e9clarations sont transmises puis analys\u00e9es par le CRPV dont d\u00e9pend la Polyn\u00e9sie Fran\u00e7aise, puis enregistr\u00e9es dans la base nationale de Pharmacovigilance g\u00e9r\u00e9e par l\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM). Une analyse des signalements est r\u00e9alis\u00e9e au niveau national mais \u00e9galement au niveau europ\u00e9en avec les autres Etats-membres.<\/span><\/p>\n<p><span style=\"font-size: 14pt;color: #4b2c68\">Elle peut mettre en \u00e9vidence un nouveau risque ou un nouveau signal. Selon sa gravit\u00e9, son caract\u00e8re inhabituel, sa fr\u00e9quence, les mesures d\u00e9j\u00e0 existantes notamment, les autorit\u00e9s de sant\u00e9 prendront les mesures n\u00e9cessaires pour r\u00e9duire ce risque (par exemple l\u2019ajout de pr\u00e9cautions d\u2019emploi, de contre-indications ou la mention du nouvel effet dans la notice patient) ou le surveilleront de fa\u00e7on plus resserr\u00e9e.<\/span><\/p>\n<\/div><\/div><\/div><div class=\"fusion-panel panel-default panel-d87483bf7c119d681 fusion-toggle-has-divider\" style=\"--awb-title-color:#333333;\"><div class=\"panel-heading\"><h4 class=\"panel-title toggle\" id=\"toggle_d87483bf7c119d681\"><a aria-expanded=\"false\" aria-controls=\"d87483bf7c119d681\" role=\"button\" data-toggle=\"collapse\" data-parent=\"#accordion-1487-1\" data-target=\"#d87483bf7c119d681\" href=\"#d87483bf7c119d681\"><span class=\"fusion-toggle-icon-wrapper\" aria-hidden=\"true\"><i class=\"fa-fusion-box active-icon awb-icon-minus\" aria-hidden=\"true\"><\/i><i class=\"fa-fusion-box inactive-icon awb-icon-plus\" aria-hidden=\"true\"><\/i><\/span><span class=\"fusion-toggle-heading\">Qu\u2019en est-il de vos donn\u00e9es personnelles ?<\/span><\/a><\/h4><\/div><div id=\"d87483bf7c119d681\" class=\"panel-collapse collapse \" aria-labelledby=\"toggle_d87483bf7c119d681\"><div class=\"panel-body toggle-content fusion-clearfix\">\n<p style=\"text-align: justify\"><span style=\"color: #4b2c68;font-size: 14pt\">Les donn\u00e9es \u00e0 caract\u00e8re personnel collect\u00e9es par l\u2019ARASS directement ou indirectement aupr\u00e8s de vous, d\u2019un de vos proches ou du professionnel de sant\u00e9 qui a collect\u00e9 les donn\u00e9es en premier lieu font l\u2019objet d\u2019un traitement automatis\u00e9 ayant pour finalit\u00e9 de renforcer les connaissances sur les effets ind\u00e9sirables du vaccin et prendre au plus t\u00f4t des mesures n\u00e9cessaires de r\u00e9duction du risque.<\/span><\/p>\n<p style=\"text-align: justify\"><span style=\"color: #4b2c68;font-size: 14pt\">Sont collect\u00e9es les coordonn\u00e9es, des donn\u00e9es d\u2019identit\u00e9 et de sant\u00e9 dont le traitement est n\u00e9cessaire pour des motifs d\u2019int\u00e9r\u00eat public et notamment l\u2019accomplissement des missions de service public de la collectivit\u00e9 relatives \u00e0 la sant\u00e9 dont l\u2019ARASS est charg\u00e9e au titre de ses missions de:<\/span><\/p>\n<ul style=\"text-align: justify\">\n<li><span style=\"color: #4b2c68;font-size: 14pt\">contr\u00f4le de la continuit\u00e9 et de la qualit\u00e9 des soins<\/span><\/li>\n<li><span style=\"color: #4b2c68;font-size: 14pt\">participation \u00e0 la s\u00e9curit\u00e9 sanitaire<\/span><\/li>\n<li><span style=\"color: #4b2c68;font-size: 14pt\">structuration et coordination de l\u2019ensemble des vigilances sanitaires institutionnelles.<\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify\"><span style=\"color: #4b2c68;font-size: 14pt\">En vertu de l\u2019arr\u00eat\u00e9 n\u00b02663 CM du 29 d\u00e9cembre 2020 relatif \u00e0 la campagne de vaccination contre la covid-19, l\u2019ARASS est charg\u00e9e d\u2019organiser le recueil des d\u00e9clarations des effets ind\u00e9sirables li\u00e9s \u00e0 la vaccination dans le cadre de ses missions de pharmacovigilance.<\/span><\/p>\n<p style=\"text-align: justify\"><span style=\"color: #4b2c68;font-size: 14pt\">Les champs marqu\u00e9s d\u2019un ast\u00e9risque sont \u00e0 ce titre obligatoire.<\/span><\/p>\n<p><span style=\"color: #4b2c68;font-size: 14pt\">Elles sont \u00e0 destination de l\u2019ARASS ainsi que du Centre r\u00e9gional de pharmacovigilance (CRPV) et de l\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM). Elles seront conserv\u00e9es le temps n\u00e9cessaire \u00e0 la r\u00e9alisation des finalit\u00e9s du traitement ou dans le respect des prescriptions l\u00e9gales.<\/span><\/p>\n<p style=\"text-align: justify\"><span style=\"color: #4b2c68;font-size: 14pt\">Conform\u00e9ment \u00e0 la loi informatique et libert\u00e9s n\u00b078-17 du 6 janvier 1978 modifi\u00e9e, vous disposez des droits suivants sur vos donn\u00e9es : droit d\u2019acc\u00e8s, droit de rectification, droit d\u2019opposition, droit \u00e0 la limitation du traitement que vous pouvez exercer aux adresses suivantes, en justifiant de votre identit\u00e9 (en cas de donn\u00e9es relatives \u00e0 la sant\u00e9, merci de vous pr\u00e9senter \u00e0 l\u2019adresse indiqu\u00e9e ci-apr\u00e8s, muni de votre pi\u00e8ce d\u2019identit\u00e9. Aucune donn\u00e9e m\u00e9dicale ne sera communiqu\u00e9e \u00e0 distance) :<\/span><\/p>\n<p style=\"text-align: center\"><span style=\"font-size: 14pt\"><strong>ARASS<\/strong><\/span><\/p>\n<p style=\"text-align: center\"><span style=\"font-size: 14pt\">BP 2551 98713 PAPEETE<\/span><\/p>\n<p style=\"text-align: center\"><span style=\"font-size: 14pt\">Courriel : <span style=\"color: #0000ff\">secretariat.arass@administration.gov.pf<\/span><\/span><\/p>\n<\/div><\/div><\/div><div class=\"fusion-panel panel-default panel-2936c07139a7a8847 fusion-toggle-has-divider\" style=\"--awb-title-color:#333333;\"><div class=\"panel-heading\"><h4 class=\"panel-title toggle\" id=\"toggle_2936c07139a7a8847\"><a aria-expanded=\"false\" aria-controls=\"2936c07139a7a8847\" role=\"button\" data-toggle=\"collapse\" data-parent=\"#accordion-1487-1\" data-target=\"#2936c07139a7a8847\" href=\"#2936c07139a7a8847\"><span class=\"fusion-toggle-icon-wrapper\" aria-hidden=\"true\"><i class=\"fa-fusion-box active-icon awb-icon-minus\" aria-hidden=\"true\"><\/i><i class=\"fa-fusion-box inactive-icon awb-icon-plus\" aria-hidden=\"true\"><\/i><\/span><span class=\"fusion-toggle-heading\">R\u00e9clamation aupr\u00e8s de la CNIL<\/span><\/a><\/h4><\/div><div id=\"2936c07139a7a8847\" class=\"panel-collapse collapse \" aria-labelledby=\"toggle_2936c07139a7a8847\"><div class=\"panel-body toggle-content fusion-clearfix\">\n<p style=\"text-align: justify\"><span style=\"font-size: 14pt\">Vous pouvez aussi introduire une r\u00e9clamation aupr\u00e8s de la CNIL ( Commission nationale de l&rsquo;informatique et des libert\u00e9s) <a href=\"http:\/\/www.cnil.fr\"><em>www.cnil.fr<\/em><\/a><em>,<\/em> sous r\u00e9serve d\u2019un manquement aux dispositions ci-dessus.<\/span><\/p>\n<p style=\"text-align: justify\"><span class=\"ILfuVd NA6bn\" style=\"font-size: 14pt\"><span class=\"hgKElc\">La Commission Nationale de l&rsquo;Informatique et des Libert\u00e9s (<b>CNIL<\/b>) a \u00e9t\u00e9 cr\u00e9\u00e9e par la loi Informatique et Libert\u00e9s du 6 janvier 1978. Elle est charg\u00e9e de veiller \u00e0 la protection des donn\u00e9es personnelles contenues dans les fichiers et traitements informatiques ou papiers, aussi bien publics que priv\u00e9s.<\/span><\/span><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-6 fusion_builder_column_1_4 1_4 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:25%;--awb-margin-top-large:0px;--awb-spacing-right-large:7.68%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:7.68%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-separator fusion-full-width-sep\" style=\"align-self: center;margin-left: auto;margin-right: auto;margin-top:154px;width:100%;\"><\/div><div class=\"fusion-flip-boxes flip-boxes row fusion-columns-1 flip-effect-classic\" style=\"--awb-flip-duration:0.8s;\"><div class=\"fusion-flip-box-wrapper fusion-column col-lg-12 col-md-12 col-sm-12\"><div class=\"fusion-flip-box flip-right\" tabindex=\"0\"><div class=\"flip-box-inner-wrapper\"><div class=\"flip-box-front\" style=\"--awb-circle-color:#000000;--awb-circle-border-color:var(--awb-color7);--awb-background-color-front:#0e4b5c;--awb-title-front-color:#ffffff;--awb-text-front-color:#ffffff;\"><div class=\"flip-box-front-inner\"><div class=\"flip-box-grafix flip-box-circle\"><i aria-hidden=\"true\" class=\"fa-address-card fas\"><\/i><\/div><h2 class=\"flip-box-heading without-text\" style=\"--h2_typography-font-size:20;\">Contact Pharmacovigilance<\/h2><\/div><\/div><div class=\"flip-box-back\" style=\"--awb-circle-color:#000000;--awb-circle-border-color:var(--awb-color7);--awb-background-color-back:#e8e8e8;--awb-title-back-color:#00475b;--awb-text-back-color:#00475b;\"><div class=\"flip-box-back-inner\">\n<p><strong>BP 2551 98713 PAPEETE<\/strong><\/p>\n<p><strong>Courriel\u00a0: <\/strong><\/p>\n<p><span style=\"font-size: 10pt\"><a href=\"mailto:vigilance.arassadministration.gov.pf\"><strong>vigilance.arass@administration.gov.pf<\/strong><\/a><\/span><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":197,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_seopress_robots_primary_cat":"","_seopress_titles_title":"Pharmacovigilance des vaccins contre la covid-19","_seopress_titles_desc":"D\u00e9clarer les effets ind\u00e9sirables des vaccins contre la COVID-19","_seopress_robots_index":"","footnotes":""},"class_list":["post-1487","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.service-public.pf\/arass\/wp-json\/wp\/v2\/pages\/1487","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.service-public.pf\/arass\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.service-public.pf\/arass\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.service-public.pf\/arass\/wp-json\/wp\/v2\/users\/197"}],"replies":[{"embeddable":true,"href":"https:\/\/www.service-public.pf\/arass\/wp-json\/wp\/v2\/comments?post=1487"}],"version-history":[{"count":13,"href":"https:\/\/www.service-public.pf\/arass\/wp-json\/wp\/v2\/pages\/1487\/revisions"}],"predecessor-version":[{"id":13255,"href":"https:\/\/www.service-public.pf\/arass\/wp-json\/wp\/v2\/pages\/1487\/revisions\/13255"}],"wp:attachment":[{"href":"https:\/\/www.service-public.pf\/arass\/wp-json\/wp\/v2\/media?parent=1487"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}