Les anti-vaccins viennent de remporter une victoire en France Temps de lecture : 5 min. BCG vaccine contains live attenuated Bacillus Calmette-Guérin (BCG) strain of Mycobacterium bovis. To estimate the true rate of adverse reactions to BCG vaccine in Canada, clear definitions of normal and adverse reactions are needed. Division of Tuberculosis Control, British Columbia Centre for Disease Control Society, Ministry of Health and University of British Columbia, Reprints or correspondence: Dr. J. Thank you for submitting a comment on this article. Composition et présentation – Vaccin bactérien vivant atténué – Poudre pour injection (vaccin lyophilisé), à dissoudre dans la totalité du solvant spécifique qui l'accompagne, en flacon multidoses. In general, the parent and family physician should be reassured about the usual benign course of such reactions. Les vaccins à éviter, lorsque l’on prend du méthotrexatesontlesvaccins«vivantsatténués»telsquele vaccin contre la fièvre jaune, contre la tuberculose (BCG), Aodhan 08/12/13. Le contenu d'un flacon est nécessaire pour une instillation intravésicale. A sternal abscess appeared 14 months after BCG revaccination of a 14-year-old girl. Frequency of Adverse Drug Reactions and Analgesic Effects of Mirogabalin during Treatment of Peripheral Neuropathic Pain: A Retrospective Clinical Investigation. Your comment will be reviewed and published at the journal's discretion. BCG vaccination is recommended for newborn babies of parents with leprosy or with a family history of leprosy. As noted earlier, the reported national rate of adverse reactions appears to be lower than the actual rate. Normalement, une fois que le BCG est donné (bras droit supérieur), une petite irruption apparaît au bout de 1 à 3 semaines et dure de 6 à 8 semaines. Culture taken from the abscess was positive for Mycobacterium bovis, which was identified as a BCG strain. Two infants developed lymphadenitis, and 57% developed suppurative nodules at the injection site. By continuing you agree to the use of cookies. BCG VACCINE should not be used in infants, children, or adults with severe immune deficiency syndromes. L'injection par voie ID est difficile chez les nouveau-nés et les jeunes nourrissons, et source d'EI locaux supplémentaires. Bacillus Calmette-Guérin (BCG), a live attenuated strain of Mycobacterium bovis, is currently the only agent approved by the US Food and Drug Administration for primary therapy of carcinoma in situ (CIS; see image below) of the bladder.BCG replaced cystectomy as the treatment of choice for CIS in the mid-1980s. Reactions to the BCG vaccine are uncommon and generally mild. Comme tous les médicaments, VACCIN BCG SSI est susceptible d'avoir des effets indésirables, bien que tout le monde n'y soit pas sujet. Il le reste cependant pour certaines professions à risque. Since then, there has been a substantial decline in the number of reported cases of adverse reactions to BCG vaccine; a total of 13 adverse reactions occurred in 1152 infants (0.01%) who were immunized. Classification ATC : ANTINEOPLASIQUES ET IMMUNOMODULATEURS: IMMUNOSTIMULANTS - IMMUNOSTIMULANTS: AUTRES IMMUNOSTIMULANTS (VACCIN BCG) Substance; bCG germe RIVM: Excipients : polygéline, glucose anhydre, polysorbate 80. excipient du solvant : sodium chlorure, eau ppi. HOW should this medicine be used? prescribing information. It is also used to treat bladder tumors or bladder cancer. Adverse reactions and complications of BCG vaccination include suppurative lymphadenitis, localized abscess (or a combination of both), and, very rarely, disseminated BCG-itis as the most serious adverse reactions to BCG vaccination. In our experience, there is often pressure to be “seen doing something,” and in that instance, there may be benefit to giving a short course of cloxacillin or erythromycin syrup if there is evidence that suggests a superimposed bacterial infection. Infection par le BCG des implants et tissus environnants (par ex. Copyright © 1988 Published by Elsevier Ltd. https://doi.org/10.1016/0041-3879(88)90043-8. Le BCG est un vaccin vivant atténué préparé à partir du microbe de la tuberculose bovine. In this article we describe a 14-year-old girl who developed a sternal BCG abscess 13 months after BCG revaccination. Une réponse excessive au Vaccin BCG SSI peut résulter en une ulcération suppurative. marqué la survenue d’effets indésirables locorégionaux, notamment des abcès. Copiii ce prezintă HIV/SIDA nu ar trebui vaccinați. Sécurité mondiale des vaccins, Vaccination, vaccins et produits biologiques 20, avenue Appia, 1211 Genève 27, Suisse. BCG vaccination is given by injecting a small amount of vaccine into the first layer of skin on the left upper arm. It must be handled as an infectious agent. BCG vaccine provides immunity or protection against tuberculosis (TB). BCG-MEDAC est introduit dans la vessie au moyen d'un cathéter sous faible pression. Copyright © 2020 Elsevier B.V. or its licensors or contributors. BCG vaccine supply for 2017 is estimated to be 1.5 times greater than the forecasted demand. Objectives To determine whether BCG vaccination protects against Mycobacterium tuberculosis infection as assessed by interferon γ release assays (IGRA) in children. Search for other works by this author on: Adverse events temporally associated with immunizing agents: 1987 report, British Columbia Ministry of Health annual reports, Neonatal vaccination with “universal strength” BCG vaccine, Second IUATLD study on complications induced by intradermal BCG vaccination, Suppurative lymphadenitis following intradermal BCG vaccination in the newborn: a preliminary report, Prospective trial of timing of bacillus Calmette-Guérin vaccination in Canadian Cree infants, Experiments in dosage requirements of BCG intradermal for infants. … Jean-Yves Nau — 10 février 2017 à 7h02. anévrisme infecté), abcès rénal . Different BCG vaccine seed strains have evolved … This is a short video on BCG vaccination. BCG has been one of the most successful immunotherapies. Many foreign-born persons have been BCG-vaccinated. Depending on the risk of acquiring TB, there may be benefits to vaccinating older children. However, when BCG vaccine is given just after birth, 7 out of 10 of infants and young children will be protected from developing severe forms of TB, e.g. Le BCG peut être administré en même temps que des vaccins inactivés (p. ex. 1987; 771. Les effets indésirables les plus fréquents sont une fièvre légère et une douleur ou une rougeur au point d’injection. 2 . VACCIN BCG SSI, poudre et solvant pour suspension injectable. Le vaccin BCG, ou vaccin contre la tuberculose, n’est plus obligatoire pour toute la population depuis 2007. Older children and adults. In this study, 42 infants received no specific therapy, 36 were treated with erythromycin stearate, 21 were treated with isoniazid, and 21 were treated with a combination of isoniazid and rifampin. Le vaccin BCG intradermique peut être administré simultanément avec d’autres vaccins inactivés ou atténués, à condition que ces derniers ne soient pas injectés dans la partie supérieure du bras gauche. Une injection trop profonde majore les risques d’abcès. A doctor experienced in the use of BCG can help decide if the vaccination will be useful. diphtérie, coqueluche, tétanos, poliomyélite) et d'autres vaccins vivants administrés par voie parentérale (p. ex. Vaccinul BCG (denumirea provine de la bacilul Calmette–Guérin) este un vaccin utilizat în principal împotriva tuberculozei. The following review defines a normal BCG response and discusses the management of complications when they occur. Surgical drainage of suppurative lymphadenitis remains controversial, with no good data to support the use of routine incision and drainage, removal, or simple needle aspiration. Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.. J’aime 0 ••• Signaler ceci; Publicité. Le vaccin BCG AJ Vaccine® ne doit pas non plus être administré aux patients recevant un traitement prophylactique antituberculeux. La culture rélisée à partir de l'abcès encapsulé extirpé a montré du Mycobacterium bovis, lequel a été identifié comme une souche BCG. An abnormal reaction involves a persistent local abscess and suppurative lymphadenopathy up to 3 months after vaccination. Most children develop a sore at the injection site. Adverse reactions to BCG vaccine appear to be grossly underreported. The vaccine will not prevent a person becoming infected with tuberculosis. Une petite cicatrice demeure une fois la vaccination guérie. Data supporting the use of isoniazid and erythromycin for the resolution of abscess formation remain inconclusive. On the basis of the above brief review of therapy for adverse reactions to BCG vaccine, the following pragmatic approach has been adopted in our program. RRO [rougeole, rubéole, oreillons,) à des points d'injection différents en utilisant des seringues et des aiguilles distinctes. 08/12/13. Rivaroxaban in Patients with Atrial Fibrillation and a Bioprosthetic Mitral Valve. Infection vasculaire (par ex. Published reports appear to underestimate the true rate of adverse reactions to bacille Calmette-Guérin (BCG) vaccine. Dr Roland Brosch, study leader . Les vaccins BCG ont un profil d’innocuité bien établi. The vaccine was launched as part of the EPI in 1974 primarily to help reduce the haematogenous spread of TB infections and the development of more severe types of TB infection (e.g. None of the children developed lymphadenitis or suppurative nodules at the injection site, and 89%–91% of the 35 who underwent tuberculin skin testing 8–9 weeks later became PPD reactive. The researchers found that a smaller dose of BCG vaccine was associated with a significantly lower rate of suppurative enlarged glands and ulceration after BCG vaccination. A 1977 study suggests 10 mm as the cutoff point for the size of a normal reaction [3]. restera obligatoire en France pour tous les enfants avant leur entrée en crèche ou à l'école. l'arrêt de la commercialisation du vaccin BCG par multipuncture par le laboratoire pharmaceutique producteur. 04.3 Données d’utilisation Selon les données GERS (ville et hôpital), environ 53 913 flacons de VACCIN BCG SSI ont été vendues en France entre janvier et décembre 2014. [9] found no significant differences in suppuration and spontaneous drainage in infants assigned to 4 different treatment groups. anévrisme infecté), abcès rénal. Il est recommandé de laisser sécher l’ulcère et d’éviter tout frottement de la plaie (par exemple, par le port de vêtements serrés). Subsequently, 72 neonates were vaccinated with 0.0125 mg (one-fourth the infant dose). The later strains were selected because they had the least side effects but maybe the efficiency has become less and les. INDICATIONS Pour l'immunisation primmre des enfants et immunisauon ou … CDC’s policies regarding tuberculosis (TB) and BCG vaccination have evolved since the publication of the joint ACET/ACIP recommendations on the use of BCG. Les vaccins . On ne réalise généralement pas de test cutané à la tuberculine avant d’administrer le vaccin BCG. Oxford University Press is a department of the University of Oxford. ARCHIVED Historical BCG Immunization Publications . Symposium Series Immunobiology, Comparison of erythromycin and isoniazid in treatment of adverse reactions to BCG vaccination. Bébé vacciné quelques heures après sa naissance ici n'a rien eu du tout. Read more about the prescription drug BCG VACCINE - INTRAVESICAL. Leeloo a eu la nouvelle version, pas d'abcès si le médecin pique bien c'est tout, donc j'ai mis la pression sur le mien :D. Pour les autres vaccins je me fie à mes lectures, à mes conversations avec les pro que je cotoie au boulot, mais ça reste un choix personnel: je ne tenterais pas de faire changer d'avis une maman. Cognitive behavioural therapy for anxiety disorders in children and adolescents. Rarely, if an enlarged lymph node becomes tense and fluctuant, it may need to be incised and drained. Because IFN-α/β has direct pleiotropic effects on the differentiation and functional activities of macrophages, we evaluated the effect of IFN-α/β on mycobacterial growth in human monocytes/macrophages in vitro. Is medical therapy effective for regional lymphadenitis following BCG vaccination? În țările unde tuberculoza sau lepra apare frecvent, este recomandată o singură doză pentru bebelușii sănătoși, iar aceasta trebuie administrată cât mai recent de la naștere. Regional lymphadenopathy in the absence of erythema or vesicle formation should also be considered a normal reaction to the vaccine [4]. Groupe: vaccin Injection intradermique. BCG vaccine is centrally supplied by PHE to the NHS in line with national policy to selectively offer vaccination to those at increased risk of exposure to tuberculosis infection. Vaccin conférant une immunité vis-à-vis des infections dues aux mycobactéries. Consult the TB website for current TB and BCG information. Consumer information about the medication BCG VACCINE - INTRAVESICAL (Theracys), includes side effects, drug interactions, recommended dosages, and storage information. The younger the infant and the larger the dose, the more likely it is that an adverse reaction will occur. Vaccin bcg ssi, poudre et solvant pour suspension injectable Vaccin genhevac b pasteur 20 microgrammes/0,5 ml,suspension injectable en seringue préremplie, vaccin de l'hépatite b recombinant During the earlier period, all children with reported reactions received specific therapy, whereas during the period with the lower vaccine dose, there not only were less adverse reactions but also fewer patients who required specific therapy (6 of 13) [2]. As noted earlier, the reported national rate of adverse reactions appears to be lower than the actual rate. In summary, adverse reactions to BCG vaccine are dose dependent and usually self-limiting. WebMD provides common contraindications for BCG Vaccine Injection. Vaccin bcg ajvaccines est un médicament sous forme de poudre et solvant pour suspension injectable. A total systems effectiveness (TSE) approach to decision-making. Two studies, one comparing isoniazid with erythromycin [8] and the other a controlled placebo study [9], showed no clear benefit from the use of either of these 2 agents for the treatment of suppurative lymphadenopathy. The BCG vaccine may cause redness and mild swelling where the injection was given. BCG vaccine side effects. Chaque ampoule contient 3 mg Sodium la-glutamate monohydrate. Malaise (7-40%) Fever (17-38%) Pain (17%) Chills (9-34%) Nausea/vomiting (3-16%) Dysuria (52-60%) Hematutia (26-39%) Urinary urgency (6-18%) Infection (2-18%) Anemia (21%) Flu-lik syndrome (24-33%) For vaccination use, refer to BCG Vaccine, U.S.P. Le vaccin BCG n'est pas requis pour les personnes qui ont déjà effectué un test cutané positif. Le premier vaccin BCG a été développé en 1921 à l’Institut Pasteur à partir d’une souche de Mycobactérium bovis provenant d’un isolement réalisé chez une vache atteinte de mammite tuberculeuse qui avait été atténuée par des passages en série. Medical therapy for lymphadenopathy is not routinely indicated. However, these symptoms should improve over time. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide, This PDF is available to Subscribers Only. The researchers noted that rapid development of lymphadenopathy—within 2 months of immunization—was associated with a higher incidence of suppuration and spontaneous drainage, irrespective of medical therapy. En Una niña de 14 años de edad apareció un absceso del esternón, 13 meses después de la revaccnación con BCG. Autorisation de mise sur le marché le 15/06/2004 par MSD VACCINS au … COMPOSITION Chaque dose humaine — 0.1 ml individuelle contient environ 0.05 mg poids humide de BCG et entre 1.5-60 x d'unités viables. Un abcès ou une cellulite d’origine infectieuse peut survenir à la suite de l’introduction de micro‑organismes lors de l’injection ou à la suite de la contamination de la fiole de vaccin. En général, une administration correcte – par voie intradermique dans la partie supérieure du bras (deltoïde) – entraîne une réaction locale qui consiste en une petite pustule donnant par la suite une cicatrice de faible ampleur. clairedelune. Un abcès du sternum est apparu 14 mois après la revaccination BCG chez une fille âgée de 14 ans. Très rare. It's given on the NHS only when a child or adult is thought to have an increased risk of coming into contact with TB. meningeal TB (affecting the brain) and miliary TB Il est tout à fait possible de faire certains vaccins en même temps, au cours d’une même consultation. During the same period, 1456 vaccines were administered, with a prevalence of 0.046% adverse reactions; of the patients with these adverse reactions, 45 had local reactions, 18 had lymphadenopathy, 3 had combined local reactions and adenopathy, and 1 had immunodeficient HIV-uninfected infant died [2]. Si la vaccination n’est pas effectuée en même temps, un intervalle d’au moins quatre semaines est requis entre deux vaccinations à germes vivants. We use cookies to help provide and enhance our service and tailor content and ads. The vaccine may be given to persons at high risk of developing TB. The Children's Vaccine Initiative and the Global Programme for Vaccines and Immunization : Recommendations from the Special Advisory Group of Experts Part I = Initiative pour les Vaccins de l'Enfance et Programme mondial des Vaccins et Vaccinations : Recommandations du Groupe consultatif spécial d'experts Partie I ScienceDirect ® is a registered trademark of Elsevier B.V. ScienceDirect ® is a registered trademark of Elsevier B.V. Sternal abscess as a complication of BCG-revaccination. Therefore, early incision was suggested. COMPOSITION QUALITATIVE ET QUANTITATIVE. Mark FitzGerald, Management of Adverse Reactions to Bacille Calmette-Guérin Vaccine, Clinical Infectious Diseases, Volume 31, Issue Supplement_3, September 2000, Pages S75–S76, https://doi.org/10.1086/314074. A normal dermatologic reaction to BCG vaccination is a red indurated area measuring 5–15 mm. The BCG vaccine used in the UK contains strains of a bacterium closely related to the one that causes TB in humans. Les vaccins contenant un adjuvant sont plus immunogènes et mieux tolérés lorsqu’ils sont administrés par voie IM. Le bacille de Calmette-Guérin (BCG) est un vaccin contre la tuberculose largement utilisé, dérivé d'une souche non infectieuse du bacille de la tuberculose bovine (Mycobacterium bovis) et principalement administré aux jeunes enfants.Habituellement, la seule réaction indésirable au vaccin est une ulcération localisée au site d'injection, pouvant laisser une petite cicatrice. J. BCG is used in many countries with a high prevalence of TB to prevent childhood tuberculous meningitis and miliary disease. Effets secondaires connus de Vaccin BCG SSI. Research Assistant Professor of Epidemiology, Board Certified or Board Eligible AP/CP Full-Time or Part-Time Pathologist, Chief of ID, VA Ann Arbor Healthcare System, Copyright © 2020 Infectious Diseases Society of America. How can we evaluate the potential of innovative vaccine products and technologies in resource constrained settings? BCG vaccination is recommended to prevent the ourrence of tuberculosis across the world, particularly for prevention of Bn and disseminated TB. Ajouter un commentaire. BCG for babies. 1988). We rarely prescribe isoniazid unless there is clear evidence of a suppurative reaction and associated lymphadenopathy and a strong desire by the parent or primary care physician to initiate such therapy. Administration. Surprisingly, from 1983 through 1987, 67 such reactions were recorded in British Columbia alone [2]. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information. This is normal and nothing to worry about. BCG-MEDAC ne doit être préparé et administré que par un professionnel de santé expérimenté. Effets indésirables . In the 1987 study of 120 infants with regional lymphadenitis after BCG vaccination, Cajlayan et al. Une attention particulière doit-être accordée à la prostatite. The 1985 study by Hanley et al. In our experience, most reactions respond to our conservative approach, and no definitive therapy is required. In Iran, BCG vaccination is performed in the neonatal age, especially at birth, the bacteria used for vaccine is Mycobacterium bovis with a concentration of 1 mg ml . BCG vaccine, vaccine against tuberculosis.The BCG vaccine is prepared from a weakened strain of Mycobacterium bovis, a bacteria closely related to M. tuberculosis, which causes the disease.The vaccine was developed over a period of 13 years, from 1908 to 1921, by French bacteriologists Albert Calmette and Camille Guérin, who named the product Bacillus Calmette-Guérin, or BCG. Administration of alpha/beta interferon (IFN-α/β) to mice infected with Mycobacterium tuberculosis has been shown to increase mycobacterial growth. The bacterium used for the vaccine is called Mycobacterium bovis, which causes TB in animals such as cows and badgers. There was significant variation in the adverse reaction reports from the different countries. l'arrêt de la commercialisation du vaccin BCG par multipuncture par le laboratoire pharmaceutique producteur. The BCG vaccine was originally developed by French scientists in 1908 who managed to make a strain of tuberculosis (TB) less potent by growing it in a glycerin-potato mixture. Det er aldrig dokumenteret, at BCG giver nogen overbevisende beskyttelse mod TB hos voksne, heller ikke af sundhedsarbejdere, som risikerer at blive erhvervsmæssigt eksponeret for TB, men hvor risikoen dog erfaringsmæssigt nu til dags er beskeden.. BCG bør overvejes: The syringe, needle, vial with unused product, and all materials exposed to the product should be disposed i… For example, in 1987 there were only 2 adverse reactions to BCG vaccine that were reported in all of Canada [1]. At 6–10 weeks, the crust falls off, leaving a flat 3- to 7-mm scar. Présentations . réaction locale : lymphadénite suppurative, abcès. Of the ∼3000 BCG immunizations completed in British Columbia from 1987 through 1992, 125 (0.24%) were associated with adverse reactions. Les autres complications régionales du BCG se résument essentiellement aux prostatites, orchi-épididymites, pyélonéphrites ou encore abcès du rein. LE VACCIN contre la tuberculose. Searches of electronic databases 1950 to November 2013, checking of reference lists, hand searching of journals, and contact with experts. Design Systematic review and meta-analysis. El cultivo practicado a partir del absceso encapsulado extirpado fue positivo para Mycobacterium bovis el cual se identificó como cepa BCG. By 2014 there were more than eight different considered biosimilar agents or strains used for the treatment of … This finding has led to the suggestion of the use of a smaller dose of vaccine (between one-fourth and one-eighth the adult dose) given at least 3 months after birth [6]. BCG vaccine contains live, viable, attenuated mycobacteria. Reassurance and a conservative therapeutic approach are usually adequate for their management [10]. Other minor side effects include red bumps at the injection site, loss of appetite, muscle or joint pain, low grade fever 1-2 days after vaccination, or enlarged lymph node. In many cases, such reassurance will be adequate. vaccin BCG lyolthilisé (Nomes Substances biologiques Commite OMS de la biologique, Techniques NO 745. none at this time . VACCIN BCG AJVaccines se présente sous la forme d’une poudre et d’un solvant pour suspension injectable (2 à 8 x 10 5 de bacilles pour une dose de 0,1 ml ou 1 à 4 x 10 5 de bacilles pour une dose de 0,05 ml). 2. În clasa a VIII-a (la vârsta de 13-14 ani) se administrează o nouă doză de vaccin BCG, numai dacă rezultatul testării IDR la tuberculină este negativ (sub 9 mm). Leprosy is very rare in Australia. The BCG vaccine (which stands for Bacillus Calmette-Guérin vaccine) is not given as part of the routine NHS vaccination schedule. [8] showed no difference in the resolution of local abscess formation in 18 infants, of whom 9 were given isoniazid therapy and 9 were given erythromycin therapy. U.S. Food and Drug Administration (FDA): Benefit-Risk Considerations for Cefiderocol (Fetroja®), A practical and economic approach for assessing potential SARS-CoV-2 transmission risk in COVID-19 patients, Hospitalization of Pediatric Enteric Fever Cases, Dhaka, Bangladesh, 2017–2019: Incidence and Risk Factors, Typhoid and Paratyphoid Cost of Illness in Pakistan: Patient and Health Facility Costs From the Surveillance for Enteric Fever in Asia Project II, Typhoid and Paratyphoid Cost of Illness in Bangladesh: Patient and Health Facility Costs From the Surveillance for Enteric Fever in Asia Project II, About the Infectious Diseases Society of America, Receive exclusive offers and updates from Oxford Academic, National Study of Adverse Reactions after Vaccination with Bacille Calmette-Guérin, Diphtheria Antitoxin Administration, Outcomes, and Safety: Response to a Diphtheria Outbreak in Cox’s Bazar Bangladesh, Inoculation Age of Bacillus Calmette-Guérin Tokyo-172 Strain and Vaccine-related Adverse Reactions in Taiwan Birth Cohort of 2012–2017, Bacille Calmette-Guérin Vaccination in Infancy Does Not Protect Against Coronavirus Disease 2019 (COVID-19): Evidence From a Natural Experiment in Sweden. La vaccination est habituellement effectuée au niveau de la zone d’insertion distale du muscle deltoïde (limite du tiers supérieur du haut du bras). CURRENT BCG Vaccine Recommendations. Following BCG vaccination it is normal to developredness and/or a small lump at the inje ction site, followed by a small ulcer (an open sore) a few weeks later. infection d'un greffon aortique, d'un défibrillateur cardiaque, d'une prothèse de hanche ou de genou), infection des ganglions lymphatiques locaux, ostéomyélite, infection de la moelle osseuse, péritonite, abcès du psoas, infection du gland du pénis, orchite ou épididymite résistant à un traitement antituberculeux A study by Guld et al. BCG osteitis occurring predominantly after primary vaccination of the newborn has been observed mainly in Finland but also in Sweden [2]. Adverse reactions and complications of BCG vaccination include suppurative lymphadenitis, localized abscess (or a combination of both), and, very rarely, disseminated BCG-itis as the most serious adverse reactions to BCG vaccination.
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