J Allergy Clin Immunol

BackgroundAnaphylaxis is a potentially life-threatening allergic reaction. The risk of anaphylaxis after vaccination has not been well described in adults or with newer vaccines in children.ObjectiveWe sought to estimate the incidence of anaphylaxis after vaccines and describe the demographic and clinical characteristics of confirmed cases of anaphylaxis.MethodsUsing health care data from the Vaccine Safety Datalink, we determined rates of anaphylaxis after vaccination in children and adults. We first identified all patients with a vaccination record from January 2009 through December 2011 and used diagnostic and procedure codes to identify potential anaphylaxis cases. Medical records of potential cases were reviewed. Confirmed cases met the Brighton Collaboration definition for anaphylaxis and had to be determined to be vaccine triggered. We calculated the incidence of anaphylaxis after all vaccines combined and for selected individual vaccines.ResultsWe identified 33 confirmed vaccine-triggered anaphylaxis cases that occurred after 25,173,965 vaccine doses. The rate of anaphylaxis was 1.31 (95% CI, 0.90-1.84) per million vaccine doses. The incidence did not vary significantly by age, and there was a nonsignificant female predominance. Vaccine-specific rates included 1.35 (95% CI, 0.65-2.47) per million doses for inactivated trivalent influenza vaccine (10 cases, 7,434,628 doses given alone) and 1.83 (95% CI, 0.22-6.63) per million doses for inactivated monovalent influenza vaccine (2 cases, 1,090,279 doses given alone). The onset of symptoms among cases was within 30 minutes (8 cases), 30 to less than 120 minutes (8 cases), 2 to less than 4 hours (10 cases), 4 to 8 hours (2 cases), the next day (1 case), and not documented (4 cases).ConclusionAnaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat.CC999999/Intramural CDC HHS/United StatesT32 AI074492/AI/NIAID NIH HHS/United States2017-03-01T00:00:00Z26452420PMC47832796146vault:3192

Curr Treat Options Allergy

Purpose of ReviewAnaphylaxis is a rare, serious hypersensitivity reaction following vaccination, which is rapid in onset and characterized by multisystem involvement. Although anaphylaxis may occur after any vaccine, understanding the risk for this outcome, particularly following influenza vaccines, is important because of the large number of persons vaccinated annually. Recent Findings Two recent CDC safety studies confirmed the rarity of post-vaccination anaphylaxis. In a 25-year review of data from the Vaccine Adverse Event Reporting System (VAERS), reports in children were most common following childhood vaccinations and among adults more often followed influenza vaccine. In a Vaccine Safety Datalink (VSD) study, the estimated incidence of anaphylaxis was 1.3 per million vaccine doses administered for all vaccines and 1.6 per million doses for IIV3 (trivalent) influenza vaccine.SummaryDespite its rarity, its rapid onset (usually within minutes) and potentially lethal nature require that all personnel and facilities providing vaccinations have procedures in place for anaphylaxis management.20192020-09-01T00:00:00ZCC999999/ImCDC/Intramural CDC HHS/United States31815089PMC6896995832

Pharmacoepidemiol Drug Saf

Purpose:To evaluate the safety of live attenuated influenza vaccine (LAIV) in children 2 through 17 years of age.Methods:The study was conducted in 6 large integrated health care organizations participating in the Vaccine Safety Datalink (VSD). Trivalent LAIV safety was assessed in children who received LAIV between September 1, 2003 and March 31, 2013. Eighteen pre\u2010specified adverse event groups were studied, including allergic, autoimmune, neurologic, respiratory, and infectious conditions. Incident rate ratios (IRRs) were calculated for each adverse event, using self\u2010controlled case series analyses. For adverse events with a statistically significant increase in risk, or an IRR > 2.0 regardless of statistical significance, manual medical record review was performed to confirm case status.Results:During the study period, 396 173 children received 590 018 doses of LAIV. For 13 adverse event groups, there was no significant increased risk of adverse events following LAIV. Five adverse event groups (anaphylaxis, syncope, Stevens\u2010Johnson syndrome, adverse effect of drug, and respiratory failure) met criteria for manual medical record review. After review to confirm cases, 2 adverse event groups remained significantly associated with LAIV: anaphylaxis and syncope. One confirmed case of anaphylaxis was observed following LAIV, a rate of 1.7 per million LAIV doses. Five confirmed cases of syncope were observed, a rate of 8.5 per million doses.Conclusions:In a study of trivalent LAIV safety in a large cohort of children, few serious adverse events were detected. Anaphylaxis and syncope occurred following LAIV, although rarely. These data provide reassurance regarding continued LAIV use.CC999999/Intramural CDC HHS/United States2019-03-28T00:00:00Z29148124PMC64376736076vault:3182

Épidémiologie des réactions d'allure allergique au vaccin contre la grippe pandémique A(H1N1)pdm09

À l’automne 2010, le Québec a réalisé une campagne de vaccination de masse contre la grippe pandémique A(H1N1) en utilisant presque exclusivement un nouveau vaccin adjuvanté à l’AS03 (Arepanrix, GlaxoSmithKline). Les données de surveillance recueillies durant la campagne de vaccination ont montré que le taux de déclaration d’anaphylaxie, une réaction systémique sévère souvent attribuable à l’allergie, s’est avéré être supérieur à celui historiquement observé avec les vaccins contre la grippe saisonnière (8 contre < 1 cas par million de doses, respectivement). De plus, l’évaluation systématique des déclarations de manifestations cliniques inhabituelles (MCI) d’allure allergique a démontré que l’anaphylaxie avait été sous-diagnostiquée parmi les cas déclarés. Plus du deux tiers des MCI d’allure allergique observées durant la campagne de vaccination contre la grippe pandémique sont survenues chez des femmes. En tenant compte du nombre de doses administrées, les femmes avaient un risque deux fois plus élevé que les hommes. De plus, ce risque était plus important durant les années de vie reproductive, soit entre l’âge de 20 et 49 ans. Notre étude cas-témoin appariée a identifié certains facteurs de risque dont l’histoire personnelle et familiale d’allergie, la présence d’une infection respiratoire et la prise de médicaments pour l’asthme dans les jours précédant la vaccination, le statut de travailleur de la santé, et une vaccination dans les 4 premières semaines de campagne. Toutefois, aucun de ces facteurs n’expliquait une grande partie des anaphylaxies ou des MCI d’allure allergique. La présence d’une allergie aux œufs ou au poisson, deux composantes potentiellement allergènes du vaccin, ne s’est pas avéré être un facteur de risque significatif de MCI d’allure allergique. Nous avons aussi réalisé une étude clinique en allergie auprès d’une centaine de cas déclarés durant la campagne de vaccination contre la grippe pandémique qui a montré que peu de ces événements pouvaient être attribuables à une allergie IgE-dépendante au vaccin ou à ses composantes. Cette recherche a mis en évidence le risque plus élevé d’anaphylaxie et de MCI d’allure allergique chez les femmes en âge reproducteur mais n’a pas réussi à identifier d’autres facteurs de risque majeurs. Elle a toutefois démontré que le mécanisme habituellement évoqué pour les expliquer soit la présence d’IgE ciblant une des composantes du vaccin semble jouer un rôle très mineur

Vaccine

Background:No comparative review of Vaccine Adverse Event Reporting System (VAERS) submissions following pandemic influenza A (H1N1) 2009 and seasonal influenza vaccinations during the pandemic season among U.S. military personnel has been published.Methods:We compared military vs. civilian adverse event reporting rates. Adverse events (AEs) following vaccination were identified from VAERS for adults aged 17\u201344 years after pandemic (monovalent influenza [MIV], and seasonal (trivalent inactivated influenza [IIV3], live attenuated influenza [LAIV3]) vaccines. Military vaccination coverage was provided by the Department of Defense\u2019s Defense Medical Surveillance System. Civilian vaccination coverage was estimated using data from the National 2009 H1N1 Flu Survey and the Behavioral Risk Factor Surveillance System survey.Results:Vaccination coverage was more than four times higher for MIV and more than twenty times higher for LAIV3 in the military than in the civilian population. The reporting rate of serious AE reports following MIV in service personnel (1.19 per 100,000) was about half that reported by the civilian population (2.45 per 100,000). Conversely, the rate of serious AE reports following LAIV3 among service personnel (1.32 per 100,000) was more than twice that of the civilian population. Although fewer military AEs following MIV were reported overall, the rate of Guillain\u2013Barr\ue9 Syndrome (GBS) (4.01 per million) was four times greater than that in the civilian population. (1.04 per million).Conclusions:Despite higher vaccination coverage in service personnel, the rate of serious AEs following MIV was about half that in civilians. The rate of GBS reported following MIV was higher in the military.20162019-04-15T00:00:00ZCC999999/Intramural CDC HHS/United States27449076PMC6463880727

Expert Opin Drug Saf

Introduction:Annual influenza vaccine safety monitoring is an important component of the influenza vaccination program in the United States to ensure that vaccines are safe, which is important for maintaining public trust in the national vaccination program. This is specially the case for influenza vaccines since the antigen composition of the viruses of which the vaccine is made often change from one season to the next, based on the circulating strain of influenza virus.Areas covered:This review describes the two surveillance systems used by the Centers for Disease Control and Prevention (CDC) to monitor the safety of influenza vaccines: 1) the Vaccine Adverse Event Reporting System (VAERS); and 2) the Vaccine Safety datalink (VSD).Expert opinion:VAERS and VSD are used routinely to monitor the safety of influenza vaccines in the United States, and over the years they have demonstrated their value in monitoring vaccine safety since their implementation in 1990. Both systems, although different, complemented each other well to study febrile seizures in young children following influenza vaccination during the 2010-2011 influenza season. Other examples of potential safety concerns after influenza vaccines are also presented and discussed.20162019-05-04T00:00:00ZCC999999/Intramural CDC HHS/United States27268157PMC6500454704

Vaccine

The Vaccine Safety Datalink (VSD) is a collaborative project between the Centers for Disease Control and Prevention (CDC) and 9 health care organizations. Established in 1990, VSD is a vital resource informing policy makers and the public about the safety of vaccines used in the United States. Large linked databases are used to identify and evaluate adverse events in over 9 million individuals annually. VSD generates rapid, important safety assessments for both routine vaccinations and emergency vaccination campaigns. VSD monitors safety of seasonal influenza vaccines in near-real time, and provided essential information on the safety of influenza A (H1N1) 2009 monovalent vaccine during the recent pandemic. VSD investigators have published important studies demonstrating that childhood vaccines are not associated with autism or other developmental disabilities. VSD prioritizes evaluation of new vaccines; searches for possible unusual health events after vaccination; monitors vaccine safety in pregnant women; and has pioneered development of biostatistical research methods.20142019-09-05T00:00:00ZCC999999/Intramural CDC HHS/United States25108215PMC6727851682

Advisory Committee on Immunization Practices (ACIP) summary report : June 20-21, 2018, Atlanta, Georgia

Publication date from document properties.min-2018-06.pdf2018704