Investigating AEFI - Vanderbilt University Medical Center

Investigating AEFI - Vanderbilt University Medical Center

Investigating Adverse Events Following Vaccination Robert C. Sparks, Research Coordinator Vanderbilt Vaccine Research Program Vanderbilt University Medical Center 1161 21st Ave. South, CCC 5319 Medical Center North Nashville, TN. 37232-2573 Investigating AEFI Adverse Event Following Immunization Who? What? When? Where? Why? Who? Can be any patient of any age, gender, race, or ethnicity..patients have been as young as 2 months old up to 70+ years of age. Totally non-discriminatory, although some populations are more susceptible to AEs,

such as those with known hypersensitivity or predisposing illness/disease What? Any vaccineMMR, Rotavirus, DtaP, Hep B, HiB, PCV, Influenza, Varicella, Hep A, Meningioccocal, YF any vaccine or combination could be a likely culprit. Investigating AEFI When? Typically the event occurs within 24 to 48 hours following administration.but it can be immediate as in the case of anaphylaxis, or delayed longereven months after the vaccine has been given. Where? The body as a whole, or specific localization is possible. For example, influenza vaccine has been associated with Guillain-Barre Syndrome (GBS), (systemic), DtaP, has been linked with big leg syndrome (localized)

Why? It could be hypersensitivity to specific components, adjuvants, preservatives, medium of transport, predisposition due to illness, age, administration error, etc. etc. Investigating AEFI Information Sources: CISA (Clinical Immunization Safety Assessment) VAERS (Vaccine Adverse Event Reporting System)

PUBLISHED ARTICLES SUBJECT MATTER EXPERTS ALLERGISTS / IMMUNOLOGISTS PATIENT AND / OR PARENT (often the best source) CISA Clinical Immunization Safety Assessment Sponsored and underwritten by CDC A network of principal investigators, coordinators, subject matter experts, associate fellows and others working together to collectively attempt to answer questions surrounding AEFI, such as causality, re-challenge, etc

Located at sites around the country, each group has unique resources available, and each month, sites discuss the more unique AEFIs in a working group teleconference CISAcont. Affiliate sites: Boston Medical Center

Columbia University Medical Center Johns Hopkins University Northern California Kaiser Permanente Stanford University Vanderbilt University Medical Center CISAcont. Key Partners: NCIRD (National Center for Immunization and Respiratory Diseases)

NVAC (National Vaccine Advisory Committee) FDA (Food and Drug Administration) HRSA (Health Resources and Services Administration) ACIP (Advisory Committee on Immunization Practice) NVPO (National Vaccine Program Office) DoD (Department of Defense) VAERS A passive database sponsored by CDC that allows the investigator to enter certain criteria or parameters to search for cases that are similar in nature. This allows the group or individual to see if there is a trend in

regards to a certain vaccine, group of symptoms, or an age or gender group. The investigator can enter groups of criteria including symptoms, vaccines, age groups, gender, U.S. reports, foreign reports, military reports, etc., and the database will search within those parameters. VAERS.cont.

VAERS LINE LIST VACCINES: PER,PPV,ROT,FLUN MedDRA PTs: ERYTHEMA MULTIFORME REPORT DATE RANGE: 01/01/2004 to 01/01/2009 Primary Records Only: YES Non-Foreign Reports Only: YES AGE IN MOS: > 6 Current Date: MAR 03, 2009(Based on VAERS data as of MAR 02, 2009) VAERS.cont. A serious spontaneous report of erythema multiforme has been received from a physician concerning a three-year-old female, subsequent to FLUMIST. Concomitant

medications included mometasone furoate, loratadine and montelukast for allergic rhinitis and congestion (patient had a prescription but physician was not sure if the patient took montelukast). On 17-Oct-2008, the patient received FLUMIST. She never received FLUMIST before. The following day on 18-Oct-2008, the child developed a rash which progressed and was described as a bullseye rash all over body. On 19-Oct-2008, the patient was hospitalized for erythema multiforme. The patient was hospitalized for three days. The reporting physician did not have the patient's hospital records. On 24-Oct-2008, the patient recovered from erythema multiforme. Additional information received on 25-Nov-2008 was incorporated into the above narrative: a diagnosis, concomitant medication, medical history, and demographics.Erythema multiforme A non-serious spontaneous report of erythema multiforme has been received from a Registered Nurse concerning a two year-old male subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient

received FLUMIST on 21-Oct-2008. The patient received a total of one dose before onset of the event which occurred three days later. On 24-Oct-2008 the child was diagnosed with erythema multiforme. It was described as "raised lesions on buttocks, legs and abdomen." The event remains unresolved with the rash present. Published Articles Vaccine adverse event monitoring systems across the European Union countries: Time for unifying efforts. Zanoni G, Berra P, Lucchi I, Ferro A, O'Flanagan D, Levy-Bruhl D, Salmaso S, Tridente G. Vaccine. 2009 Feb 5. [Epub ahead of print] PMID: 19200851 [PubMed - as supplied by publisher] Acute cerebellar ataxia in the Netherlands: A study on the association with vaccinations and varicella zoster infection. Vaccine. 2009 van der Maas NA, Bondt PE, de Melker H, Kemmeren JM.

Mar 18;27(13):1970-3. Epub 2009 Jan 30. PMID: 19186201 [PubMed - in process] Factors determining utilization of a Web site by parents in order to report side effects of vaccines. Kimpton A, Dub E, Sauvageau C, De Serres G. Can J Public Health. 2008 Nov-Dec;99(6):456-9. French. PMID: 19149385 [PubMed - indexed for MEDLINE] Published Articlescont. Safety and efficacy of a novel microneedle device for dose sparing intradermal influenza vaccination in healthy adults. Van Damme P, Oosterhuis-Kafeja F, Van der Wielen M, Almagor Y, Sharon O, Levin Y. Vaccine. 2009 Jan 14;27(3):454-9. Epub 2008 Nov 18. PMID: 19022318 [PubMed - indexed for MEDLINE]

Adverse events after anthrax vaccination reported to the Vaccine Adverse Event Reporting System (VAERS), 1990-2007. Niu MT, Ball R, Woo EJ, Burwen DR, Knippen M, Braun MM; VAERS Working Group. Vaccine. 2009 Jan 7;27(2):290-7. Epub 2008 Nov 6. PMID: 18992783 [PubMed - indexed for MEDLINE] Subject Matter Experts, Allergists/Immunologists Kathryn Edwards, MD Sarah Sell Chair in Pediatrics, Vice Chair Pediatrics, Director Vanderbilt Vaccine Research Program Melvin Berger, MD, PhD, Senior Medical Director Clinical R&D, CSL Behring, LLC Stephen C, Dreskin, MD Professor of Medicine,

Univ of Colorado,Practice Director, Allergy and Immunology Jim Sejvar, MD, Neuroepidemiologist, CDC, Brighton Collaboration Subject Matter Experts, Allergists/Immunologists (cont.) Collin Marchant, MD, Boston Medical Center Phil LaRussa, MD, Columbia University Medical Center Neal Halsey, MD, Johns Hopkins University Nicky Klein, MD, Roger Baxter, MD, Northern California Kaiser Permanente Cornelia Dekker, MD, Stanford University

Investigating AEFI Many facets of investigation and information gathering go into critically examining an AEFI to determine if a causative factor can be determined, as well as attempting to reach a consensus in treatment of the event, and/or preventing a recurrence, particularly in cases where multiple doses are required to convey immunity. Sometimes that is not possible, as the information conflicts itself, such as is evidenced in published articles, or the risk of rechallenge is too great as in the case of known anaphylaxis. Investigating AEFI Conclusion: Multiple avenues are available to answer the

questions associated with AEFI. While a perfect approach to a solution is not always possible, the questions that do arise, often support more research to that end. A mixture of databases, published articles that address related issues, and a network of recognized leaders in the field all work in a collective effort to seek an answer. Each case must be looked at separately and the approach, while structured, often varies, but an open ended approach is key to attempting to find a causative factor, and addressing the question of future immunization.

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