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  1. Article ; Online: Incidence of anaphylaxis to YF-VAX® yellow fever vaccination: a retrospective evaluation of vaccine adverse event reports 1999-2018.

    McClenathan, Bruce M / Taylor, Jillian N / Housel, Laurie A / Ryan, Margaret

    Journal of travel medicine

    2023  Volume 31, Issue 2

    Abstract: Background: The incidence of anaphylaxis after receipt of yellow fever (YF) vaccine is highly variable based upon previously published reports. Anaphylaxis after receiving the YF vaccine has been reported to range from 0 up to 22 per 1 000 000 doses. ... ...

    Abstract Background: The incidence of anaphylaxis after receipt of yellow fever (YF) vaccine is highly variable based upon previously published reports. Anaphylaxis after receiving the YF vaccine has been reported to range from 0 up to 22 per 1 000 000 doses. Our clinical experience suggested increased incidence, which prompted our investigation. We sought to evaluate the current incidence rate of anaphylaxis after receipt of the 17D-204 strain YF-VAX® brand reported in the US.
    Methods: We performed a retrospective review of the Vaccine Adverse Event Reporting System (VAERS) reports of anaphylaxis after receiving the YF-VAX vaccine occurring between 1 October 1999 and 30 September 2018. We utilized the Brighton Collaboration Case Definition and inclusion determination was made by a board-certified allergist. We also obtained the total number of YF-VAX doses distributed across the US during this same time-period and then calculated an updated incidence rate of YF-VAX vaccine-associated anaphylaxis.
    Results: We identified 132 potential cases of possible or probable anaphylaxis. Of these, 111 met inclusion criteria: level 1 (n = 51), level 2 (n = 59) and level 3 (n = 1). The manufacturer reported a total distribution of 7 624 160 doses of YF-VAX from 1 October 1999 to 30 September 2018. The calculated incidence rate of YF-VAX vaccine-associated anaphylaxis is estimated at 14.6 events per 1 000 000 doses.
    Conclusions: We conclude the estimated rate of anaphylaxis per VAERS reports is 14.6 events per 1 000 000 doses after YF-VAX vaccination. This is consistent with some previous reports and substantially higher than rates of anaphylaxis after other vaccines.
    MeSH term(s) Humans ; Anaphylaxis/chemically induced ; Anaphylaxis/epidemiology ; Incidence ; Retrospective Studies ; Vaccination/adverse effects ; Yellow Fever/epidemiology ; Yellow Fever/prevention & control ; Yellow Fever Vaccine/adverse effects
    Chemical Substances Yellow Fever Vaccine
    Language English
    Publishing date 2023-12-05
    Publishing country England
    Document type Journal Article
    ZDB-ID 1212504-0
    ISSN 1708-8305 ; 1195-1982
    ISSN (online) 1708-8305
    ISSN 1195-1982
    DOI 10.1093/jtm/taad154
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Herpes zoster after recombinant zoster vaccine: A first case report.

    Housel, Laurie A / McClenathan, Bruce M

    The journal of allergy and clinical immunology. In practice

    2019  Volume 8, Issue 2, Page(s) 772–774.e1

    MeSH term(s) Herpes Zoster/diagnosis ; Herpes Zoster Vaccine ; Herpesvirus 3, Human ; Humans
    Chemical Substances Herpes Zoster Vaccine
    Language English
    Publishing date 2019-08-02
    Publishing country United States
    Document type Case Reports ; Journal Article
    ZDB-ID 2843237-X
    ISSN 2213-2201 ; 2213-2198
    ISSN (online) 2213-2201
    ISSN 2213-2198
    DOI 10.1016/j.jaip.2019.07.033
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article: Cardiac Adverse Events Following COVID-19 Vaccination in Patients With Prior Vaccine-Associated Myocarditis.

    Montgomery, Jay R / Hoffman, Donna L / Ryan, Margaret A / Lee, Rachel U / Housel, Laurie A / Engler, Renata J / Collins, Limone C / Atwood, John E / Cooper, Leslie T

    Federal practitioner : for the health care professionals of the VA, DoD, and PHS

    2023  Volume 40, Issue 1, Page(s) 6–10

    Abstract: Background: Limited information exists to guide shared clinical decision making on COVID-19 vaccination in persons with a prior history of vaccine-associated myocarditis, pericarditis, or myopericarditis (VAMP). The objective of this retrospective ... ...

    Abstract Background: Limited information exists to guide shared clinical decision making on COVID-19 vaccination in persons with a prior history of vaccine-associated myocarditis, pericarditis, or myopericarditis (VAMP). The objective of this retrospective observational case series was to characterize cardiac outcomes within 30 days following receipt of 1 or more COVID-19 vaccinations during 2021 in US service members diagnosed with prior non-COVID-19 VAMP between 1998 and 2019.
    Methods: As part of the collaborative public health mission with the Centers for Disease Control and Prevention for enhanced vaccine adverse events surveillance, the Defense Health Agency Immunization Healthcare Division maintains a clinical database of service members and beneficiaries referred for suspected adverse events following immunizations. Cases in this database recorded between January 1, 2003, and February 28, 2022, were reviewed to identify individuals with prior VAMP who received a COVID-19 vaccine in 2021 and developed signs or symptoms suggestive of VAMP within 30 days following COVID-19 vaccination.
    Results: Before the COVID-19 pandemic, 431 service members had verified VAMP. Among these 431 patients, 179 had records that confirmed receipt of a COVID-19 vaccine in 2021. Of these 179 patients, 171 (95.5%) were male. Their median age was 39 years (range, 21-67) at the time of COVID-19 vaccination. Most (n = 172; 96.1%) experienced their original VAMP episode after receipt of the live replicating smallpox vaccine. Eleven patients experienced cardiac-suggestive symptoms (chest pain, palpitations, or dyspnea) within 30 days of COVID-19 vaccination. Four patients met the criteria for recurrent VAMP. Three men aged 49, 50, and 55 years developed myocarditis within 3 days of an mRNA COVID-19 vaccine. One 25-year-old man developed pericarditis within 4 days of receiving an mRNA vaccine. All 4 COVID-19 recurrent VAMP cases fully recovered with minimal supportive care within weeks (myocarditis) to months (pericarditis).
    Conclusions: As demonstrated by this case series, albeit rare, VAMP may reoccur after COVID-19 vaccination among patients who experienced cardiac injury after smallpox vaccination. The clinical characteristics and course of the 4 recurring cases were mild, appearing similar to the post-COVID-19 VAMP described in individuals without a history of VAMP. More research is warranted on factors that may predispose patients to vaccine-associated cardiac injury and which vaccine platforms or schedules may reduce the risk of recurrence among patients who have experienced these events.
    Language English
    Publishing date 2023-01-17
    Publishing country United States
    Document type Journal Article
    ISSN 1078-4497
    ISSN 1078-4497
    DOI 10.12788/fp.0354
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: A randomized controlled trial of NSAIDs or exercise to reduce delayed local pain after influenza vaccination.

    Housel, Laurie A / Beltran, Thomas A / Spooner, Christina / Collins, Limone C / Ewing, Daniel F / Williams, Maya / McClenathan, Bruce M

    The journal of allergy and clinical immunology. In practice

    2020  Volume 9, Issue 2, Page(s) 1018–1020.e1

    MeSH term(s) Anti-Inflammatory Agents, Non-Steroidal/therapeutic use ; Exercise ; Humans ; Influenza Vaccines ; Influenza, Human/prevention & control ; Pain ; Vaccination
    Chemical Substances Anti-Inflammatory Agents, Non-Steroidal ; Influenza Vaccines
    Language English
    Publishing date 2020-09-12
    Publishing country United States
    Document type Journal Article ; Randomized Controlled Trial ; Research Support, U.S. Gov't, Non-P.H.S.
    ZDB-ID 2843237-X
    ISSN 2213-2201 ; 2213-2198
    ISSN (online) 2213-2201
    ISSN 2213-2198
    DOI 10.1016/j.jaip.2020.08.058
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Myocarditis and pericarditis recovery following smallpox vaccine 2002-2016: A comparative observational cohort study in the military health system.

    Engler, Renata J M / Montgomery, Jay R / Spooner, Christina E / Nelson, Michael R / Collins, Limone C / Ryan, Margaret A / Chu, Clara S / Atwood, John E / Hulten, Edward A / Rutt, Ahlea A / Parish, Dacia O / McClenathan, Bruce M / Hrncir, David E / Duran, Laurie / Skerrett, Catherine / Housel, Laurie A / Brunader, Janet A / Ryder, Stephanie L / Lohsl, Connie L /
    Hemann, Brian A / Cooper, Leslie T

    PloS one

    2023  Volume 18, Issue 5, Page(s) e0283988

    Abstract: Objectives: (1) Characterize the initial clinical characteristics and long-term outcomes of smallpox vaccine-associated hypersensitivity myocarditis and pericarditis (MP) in United States service members. (2) Describe the process of case identification ... ...

    Abstract Objectives: (1) Characterize the initial clinical characteristics and long-term outcomes of smallpox vaccine-associated hypersensitivity myocarditis and pericarditis (MP) in United States service members. (2) Describe the process of case identification and adjudication using the 2003 CDC nationally defined myocarditis/pericarditis epidemiologic case definitions to include consideration of case-specific diversity and evolving evidence.
    Background: Between 2002 and 2016, 2.546 million service members received a smallpox Vaccinia vaccine. Acute MP is associated with vaccinia, but the long-term outcomes have not been studied.
    Methods: Records of vaccinia-associated MP reported to the Vaccine Adverse Event Reporting System by vaccination date were adjudicated using the 2003 MP epidemiologic case definitions for inclusion in a retrospective observational cohort study. Descriptive statistics of clinical characteristics, presentation, cardiac complications, and time course of clinical and cardiac recovery were calculated with comparisons by gender, diagnosis and time to recovery.
    Results: Out of over 5000 adverse event reports, 348 MP cases who survived the acute illness, including 276 myocarditis (99.6% probable/confirmed) and 72 pericarditis (29.2% probable/confirmed), were adjudicated for inclusion in the long-term follow-up. Demographics included a median age of 24 years (IQR 21,30) and male predominance (96%). Compared to background military population, the myocarditis and pericarditis cohort had a higher percentage of white males by 8.2% (95% CI: 5.6, 10.0) and age <40 years by 4.2% (95% CI: 1.7,5.8). Long-term follow-up documented full recovery in 267/306 (87.3%) with 74.9% recovered in less than a year (median ~3 months). Among patients with myocarditis, the percentage who had a delayed time to recovery at time of last follow-up was 12.8% (95% CI: 2.1,24.7) higher in those with an acute left ventricular ejection fraction (EF) of ≤50% and 13.5% (95% CI: 2.4,25.7) higher in those with hypokinesis. Patient complications included 6 ventricular arrhythmias (2 received implanted defibrillators) and 14 with atrial arrhythmias (2 received radiofrequency ablation). Three of 6 patients (50%) diagnosed with cardiomyopathy had clinical recovery at their last follow-up date.
    Conclusions: Hypersensitivity myocarditis/pericarditis following the smallpox vaccine is associated with full clinical and functional ventricular recovery in over 87% of cases (74.9% <1 year). A minority of MP cases experienced prolonged or incomplete recovery beyond 1 year.
    MeSH term(s) Humans ; Male ; United States ; Adult ; Female ; Smallpox Vaccine/adverse effects ; Myocarditis/epidemiology ; Myocarditis/etiology ; Myocarditis/diagnosis ; Vaccinia/prevention & control ; Retrospective Studies ; Military Health Services ; Stroke Volume ; Ventricular Function, Left ; Vaccination ; Pericarditis/epidemiology ; Pericarditis/etiology ; Pericarditis/diagnosis ; Smallpox/prevention & control ; Vaccinia virus
    Chemical Substances Smallpox Vaccine
    Language English
    Publishing date 2023-05-08
    Publishing country United States
    Document type Observational Study ; Journal Article
    ZDB-ID 2267670-3
    ISSN 1932-6203 ; 1932-6203
    ISSN (online) 1932-6203
    ISSN 1932-6203
    DOI 10.1371/journal.pone.0283988
    Database MEDical Literature Analysis and Retrieval System OnLINE

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