LIVIVO - Search results -

Search results

Result 1 - 10 of total 17

Search options

Article ; Online: Comparative frequency of specified adverse events following Vero cell culture-derived Japanese encephalitis and Vi capsular polysaccharide typhoid vaccines in U.S. military personnel, July 2011-August 2019.

Seshadri, Srihari / Martin, Stacey W / Hills, Susan L / Collins, Limone C

2023 Volume 41, Issue 9, Page(s) 1537–1540

Abstract: Vero cell culture-derived Japanese encephalitis (JE) vaccine (JE-VC; Ixiaro) was approved in the United States in 2009. The previous JE vaccine, an inactivated mouse brain-derived vaccine, had been associated with rare, but serious, allergic and ... ...

Abstract	Vero cell culture-derived Japanese encephalitis (JE) vaccine (JE-VC; Ixiaro) was approved in the United States in 2009. The previous JE vaccine, an inactivated mouse brain-derived vaccine, had been associated with rare, but serious, allergic and neurologic adverse events (AE). Studies and AE surveillance have supported JE-VC's safety, but one evaluation among military personnel found elevated hypersensitivity and neurologic AE rates. However, co-administration of multiple vaccines to some personnel might have affected results. We retrospectively compared rates of hypersensitivity and neurologic AEs within 28 days following vaccination of military personnel with JE-VC or parenteral Vi capsular polysaccharide typhoid vaccine administered without other vaccines from July 1, 2011, through August 31, 2019. Rates of most events were similar between the vaccines. Only delayed hypersensitivity reactions occurred more frequently following JE-VC (rate ratio: 4.2, 95 % CI 1.2-15.3; p = 0.03), but rates were low for both vaccines. These results support JE-VC's safety.
MeSH term(s)	Animals ; Chlorocebus aethiops ; Mice ; United States ; Humans ; Encephalitis, Japanese/prevention & control ; Typhoid-Paratyphoid Vaccines ; Military Personnel ; Retrospective Studies ; Japanese Encephalitis Vaccines ; Vero Cells ; Hypersensitivity ; Vaccines, Inactivated ; Polysaccharides ; Cell Culture Techniques
Chemical Substances	Typhoid-Paratyphoid Vaccines ; Japanese Encephalitis Vaccines ; Vaccines, Inactivated ; Polysaccharides
Language	English
Publishing date	2023-01-30
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2023.01.061
Database	MEDical Literature Analysis and Retrieval System OnLINE

Full text online

Accessible to users with ZB MED library card

In stock of ZB MED Cologne/Königswinter

Zs.A 1930: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 458: Show issues

Order via subito

This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

Details ▾

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

Order via subito

Inter-library loan at ZB MED

Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

Article: Enhanced safety surveillance study of ACAM2000 smallpox vaccine among US military service members

Decker, Michael D. / Garman, Patrick M. / Hughes, Hayley / Yacovone, Margaret A. / Collins, Limone C. / Fegley, Christopher D. / Lin, Grace / DiPietro, Gina / Gordon, Daniel M.

Elsevier Ltd Vaccine. 2021 Sept. 15, v. 39, no. 39

2021

Abstract: To evaluate the rates of myopericarditis (primary objective) and rates of cardiovascular and neurological adverse events (secondary objectives) in temporal association with ACAM2000® smallpox vaccine.Observational cohort study conducted through monthly ... ...

Abstract	To evaluate the rates of myopericarditis (primary objective) and rates of cardiovascular and neurological adverse events (secondary objectives) in temporal association with ACAM2000® smallpox vaccine.Observational cohort study conducted through monthly surveillance from 2009 to 2017 of electronic medical records of military service members (SM) for pre-specified cardiac and neurological International Classification of Diseases (ICD) codes reported in the 30 days following smallpox vaccination. ICD codes potentially predictive of myopericarditis and codes for encephalitis, Guillain-Barré syndrome, and sudden death were classified into Group 1. All other cardiovascular and neurological ICD codes were classified into Group 2. Medical records containing Group 1 codes were individually reviewed to confirm coding accuracy and to seek additional data in support of myopericarditis adjudication, which was performed by an independent clinical panel. Chart reviews were not performed for Group 2 codes, which were reported in aggregate only.897,227 SM who received ACAM2000 smallpox vaccine and 450,000 SM who received Dryvax smallpox vaccine were included in the surveillance population. The rate of adjudicated myopericarditis among ACAM2000 smallpox vaccine recipients was 20.06/100,000 and was significantly higher for males (21.8/100,000) than females (8.5/100,000) and for those < 40 years of age (21.1/100,000) than for those 40 years or older (6.3/100,000). Overall rates for any cardiovascular event (Group 1 plus Group 2) were 113.5/100,000 for ACAM2000 vaccine and 439.3/100,000 for Dryvax vaccine; rate ratio, 0.26 (95% CI, 0.24–0.28). The rates of subjects with one or more defined neurological events were 2.12/100,000 and 1.11/100,000 for ACAM2000 and Dryvax vaccines respectively; rate ratio, 1.91 (95% CI, 0.71–5.10).Electronic records surveillance of the entire vaccinated SM population over a ten-year period found rates of myopericarditis, of defined neurological events, and of overall cardiac events that were consistent with those of prior passive surveillance studies involving Dryvax or ACAM2000 smallpox vaccines.Clinical trials registration: ClinicalTrials.gov NCT00927719.
Keywords	cohort studies ; death ; encephalitis ; monitoring ; smallpox ; vaccination ; vaccines
Language	English
Dates of publication	2021-0915
Size	p. 5541-5547.
Publishing place	Elsevier Ltd
Document type	Article
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2021.08.041
Database	NAL-Catalogue (AGRICOLA)

Full text online

Accessible to users with ZB MED library card

In stock of ZB MED Cologne/Königswinter

Zs.A 1930: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 458: Show issues

Order via subito

Details ▾

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

In stock of ZB MED Cologne/Königswinter

Zs.A 7086: Show issues

Location:
Je nach Verfügbarkeit (siehe Angabe bei Bestand)
bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
ab Jg. 2022: Lesesaal (EG)

Order via subito

Details ▾
- See ZB MED holdings
- Order with fees

Article: Insufficient Anthrax Lethal Toxin Neutralization Is Associated with Antibody Subclass and Domain Specificity in the Plasma of Anthrax-Vaccinated Individuals

Smith, Kenneth / Garman, Lori / Norris, Kathleen / Muther, Jennifer / Duke, Angie / Engler, Renata J. M. / Nelson, Michael R. / Collins, Limone C. / Spooner, Christina / Guthridge, Carla / James, Judith A.

Microorganisms. 2021 June 02, v. 9, no. 6

2021

Abstract: Anthrax vaccine adsorbed (AVA) is a significant line of defense against bioterrorist attack from Bacillus anthracis spores. However, in a subset of individuals, this vaccine may produce a suboptimal quantity of anti-protective antigen (PA), antibodies ... ...

Abstract	Anthrax vaccine adsorbed (AVA) is a significant line of defense against bioterrorist attack from Bacillus anthracis spores. However, in a subset of individuals, this vaccine may produce a suboptimal quantity of anti-protective antigen (PA), antibodies that are poorly neutralizing, and/or antibody titers that wane over time, necessitating annual boosters. To study individuals with such poor responses, we examine the properties of anti-PA in a subset of vaccinated individuals that make significant quantities of antibody but are still unable to neutralize toxin. In this cohort, characterized by poorly neutralizing antibody, we find that increased IgG4 to IgG1 subclass ratios, low antibody avidity, and insufficient antibody targeting domain 4 associate with improper neutralization. Thus, future vaccines and vaccination schedules should be formulated to improve these deficiencies.
Keywords	Bacillus anthracis ; anthrax ; anthrax vaccines ; antibody affinity ; antigens ; immunoglobulin G ; neutralization ; toxins ; vaccination
Language	English
Dates of publication	2021-0602
Publishing place	Multidisciplinary Digital Publishing Institute
Document type	Article
ZDB-ID	2720891-6
ISSN	2076-2607
ISSN	2076-2607
DOI	10.3390/microorganisms9061204
Database	NAL-Catalogue (AGRICOLA)

Order via subito

Article: Insufficient Anthrax Lethal Toxin Neutralization Is Associated with Antibody Subclass and Domain Specificity in the Plasma of Anthrax-Vaccinated Individuals.

Smith, Kenneth / Garman, Lori / Norris, Kathleen / Muther, Jennifer / Duke, Angie / Engler, Renata J M / Nelson, Michael R / Collins, Limone C / Spooner, Christina / Guthridge, Carla / James, Judith A

Microorganisms

2021 Volume 9, Issue 6

Abstract: Anthrax vaccine adsorbed (AVA) is a significant line of defense against bioterrorist attack ... ...

Abstract	Anthrax vaccine adsorbed (AVA) is a significant line of defense against bioterrorist attack from
Language	English
Publishing date	2021-06-02
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2720891-6
ISSN	2076-2607
ISSN	2076-2607
DOI	10.3390/microorganisms9061204
Database	MEDical Literature Analysis and Retrieval System OnLINE

Order via subito

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

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

Order via subito

Article ; Online: Adverse events following adenovirus type 4 and type 7 vaccine, live, oral in the Vaccine Adverse Event Reporting System (VAERS), United States, October 2011-July 2018.

McNeil, Michael M / Paradowska-Stankiewicz, Iwona / Miller, Elaine R / Marquez, Paige L / Seshadri, Srihari / Collins, Limone C / Cano, Maria V

Vaccine

2019 Volume 37, Issue 44, Page(s) 6760–6767

Abstract: Background: In March 2011, the U.S. Food and Drug Administration licensed adenovirus type 4 and type 7 vaccine, live, oral (Barr Labs, Inc.) (adenovirus vaccine) for use in military personnel 17 through 50 years of age. The vaccine was first universally ...

Abstract	Background: In March 2011, the U.S. Food and Drug Administration licensed adenovirus type 4 and type 7 vaccine, live, oral (Barr Labs, Inc.) (adenovirus vaccine) for use in military personnel 17 through 50 years of age. The vaccine was first universally administered to U.S. military recruits in October 2011. We investigated adverse event (AE) reports following the adenovirus vaccine submitted to the Vaccine Adverse Event Reporting System (VAERS). Methods: We searched the VAERS database for U.S. reports among persons who received adenovirus vaccine during October 2011 through July 2018 including participants in a military observational study. We reviewed all serious reports and accompanying medical records. We compared the proportion of serious reports in a proxy military recruit population and reviewed all reports of suspected allergic reactions following adenovirus vaccination. Results: During the analytic period, VAERS received 100 reports following adenovirus vaccination; 39 (39%) were classified as serious and of these, 17 (44%) were from the observational study. One death was reported. Males accounted for 72% of reports. Median age of vaccinees was 19 years (range 17-32). The most frequently reported serious AEs were Guillain Barré syndrome (GBS) (n = 12) and anaphylaxis (n = 8); of these, two GBS and all the anaphylaxis reports were reported in the observational study. Reports documented concurrent receipt of multiple other vaccines (95%) and penicillin G (IM Pen G) or other antibiotics (50%). Conclusions: The reporting rate for serious AEs was higher than with other vaccines administered in the comparison military recruit population (39% vs 18%); however, we identified no unexpected or concerning pattern of adenovirus vaccine AEs. Co-administration of vaccines and IM Pen G was commonly reported in this military population. These exposures may have contributed to the GBS and anaphylaxis outcomes observed with the adenovirus vaccine. Future adenovirus vaccine safety studies in a population without these co-administrations would be helpful in clarifying the vaccine's safety profile.
MeSH term(s)	Adenoviridae/classification ; Adenoviridae/immunology ; Adenoviridae Infections/prevention & control ; Adenovirus Vaccines/administration & dosage ; Adenovirus Vaccines/adverse effects ; Adenovirus Vaccines/immunology ; Adolescent ; Adult ; Adverse Drug Reaction Reporting Systems ; Anaphylaxis/epidemiology ; Anaphylaxis/prevention & control ; Databases, Factual ; Drug-Related Side Effects and Adverse Reactions/epidemiology ; Drug-Related Side Effects and Adverse Reactions/history ; Female ; History, 21st Century ; Humans ; Male ; Pregnancy ; Risk Assessment ; Risk Factors ; United States/epidemiology ; Young Adult
Chemical Substances	Adenovirus Vaccines
Language	English
Publishing date	2019-09-20
Publishing country	Netherlands
Document type	Historical Article ; Journal Article ; Research Support, U.S. Gov't, P.H.S.
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2019.08.087
Database	MEDical Literature Analysis and Retrieval System OnLINE

Full text online

Accessible to users with ZB MED library card

In stock of ZB MED Cologne/Königswinter

Zs.A 1930: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 458: Show issues

Order via subito

Details ▾

Article ; Online: Enhanced safety surveillance study of ACAM2000 smallpox vaccine among US military service members.

Decker, Michael D / Garman, Patrick M / Hughes, Hayley / Yacovone, Margaret A / Collins, Limone C / Fegley, Christopher D / Lin, Grace / DiPietro, Gina / Gordon, Daniel M

Vaccine

2021 Volume 39, Issue 39, Page(s) 5541–5547

Abstract: Objectives: To evaluate the rates of myopericarditis (primary objective) and rates of cardiovascular and neurological adverse events (secondary objectives) in temporal association with ACAM2000® smallpox vaccine.: Methods: Observational cohort study ... ...

Abstract	Objectives: To evaluate the rates of myopericarditis (primary objective) and rates of cardiovascular and neurological adverse events (secondary objectives) in temporal association with ACAM2000® smallpox vaccine. Methods: Observational cohort study conducted through monthly surveillance from 2009 to 2017 of electronic medical records of military service members (SM) for pre-specified cardiac and neurological International Classification of Diseases (ICD) codes reported in the 30 days following smallpox vaccination. ICD codes potentially predictive of myopericarditis and codes for encephalitis, Guillain-Barré syndrome, and sudden death were classified into Group 1. All other cardiovascular and neurological ICD codes were classified into Group 2. Medical records containing Group 1 codes were individually reviewed to confirm coding accuracy and to seek additional data in support of myopericarditis adjudication, which was performed by an independent clinical panel. Chart reviews were not performed for Group 2 codes, which were reported in aggregate only. Results: 897,227 SM who received ACAM2000 smallpox vaccine and 450,000 SM who received Dryvax smallpox vaccine were included in the surveillance population. The rate of adjudicated myopericarditis among ACAM2000 smallpox vaccine recipients was 20.06/100,000 and was significantly higher for males (21.8/100,000) than females (8.5/100,000) and for those < 40 years of age (21.1/100,000) than for those 40 years or older (6.3/100,000). Overall rates for any cardiovascular event (Group 1 plus Group 2) were 113.5/100,000 for ACAM2000 vaccine and 439.3/100,000 for Dryvax vaccine; rate ratio, 0.26 (95% CI, 0.24-0.28). The rates of subjects with one or more defined neurological events were 2.12/100,000 and 1.11/100,000 for ACAM2000 and Dryvax vaccines respectively; rate ratio, 1.91 (95% CI, 0.71-5.10). Conclusions: Electronic records surveillance of the entire vaccinated SM population over a ten-year period found rates of myopericarditis, of defined neurological events, and of overall cardiac events that were consistent with those of prior passive surveillance studies involving Dryvax or ACAM2000 smallpox vaccines. Clinical trials registration: ClinicalTrials.gov NCT00927719.
MeSH term(s)	Adult ; Female ; Humans ; Male ; Military Personnel ; Smallpox ; Smallpox Vaccine/adverse effects ; Vaccination
Chemical Substances	ACAM2000 ; Smallpox Vaccine
Language	English
Publishing date	2021-08-26
Publishing country	Netherlands
Document type	Journal Article ; Observational Study ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2021.08.041
Database	MEDical Literature Analysis and Retrieval System OnLINE

Full text online

Accessible to users with ZB MED library card

In stock of ZB MED Cologne/Königswinter

Zs.A 1930: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 458: Show issues

Order via subito

Details ▾

Article: Adverse events following adenovirus type 4 and type 7 vaccine, live, oral in the Vaccine Adverse Event Reporting System (VAERS), United States, October 2011–July 2018

McNeil, Michael M / Cano, Maria V / Collins, Limone C / Marquez, Paige L / Miller, Elaine R / Paradowska-Stankiewicz, Iwona / Seshadri, Srihari

Vaccine. 2019 Oct. 16, v. 37, no. 44

2019

Abstract: In March 2011, the U.S. Food and Drug Administration licensed adenovirus type 4 and type 7 vaccine, live, oral (Barr Labs, Inc.) (adenovirus vaccine) for use in military personnel 17 through 50 years of age. The vaccine was first universally administered ...

Abstract	In March 2011, the U.S. Food and Drug Administration licensed adenovirus type 4 and type 7 vaccine, live, oral (Barr Labs, Inc.) (adenovirus vaccine) for use in military personnel 17 through 50 years of age. The vaccine was first universally administered to U.S. military recruits in October 2011. We investigated adverse event (AE) reports following the adenovirus vaccine submitted to the Vaccine Adverse Event Reporting System (VAERS).We searched the VAERS database for U.S. reports among persons who received adenovirus vaccine during October 2011 through July 2018 including participants in a military observational study. We reviewed all serious reports and accompanying medical records. We compared the proportion of serious reports in a proxy military recruit population and reviewed all reports of suspected allergic reactions following adenovirus vaccination.During the analytic period, VAERS received 100 reports following adenovirus vaccination; 39 (39%) were classified as serious and of these, 17 (44%) were from the observational study. One death was reported. Males accounted for 72% of reports. Median age of vaccinees was 19 years (range 17–32). The most frequently reported serious AEs were Guillain Barré syndrome (GBS) (n = 12) and anaphylaxis (n = 8); of these, two GBS and all the anaphylaxis reports were reported in the observational study. Reports documented concurrent receipt of multiple other vaccines (95%) and penicillin G (IM Pen G) or other antibiotics (50%).The reporting rate for serious AEs was higher than with other vaccines administered in the comparison military recruit population (39% vs 18%); however, we identified no unexpected or concerning pattern of adenovirus vaccine AEs. Co-administration of vaccines and IM Pen G was commonly reported in this military population. These exposures may have contributed to the GBS and anaphylaxis outcomes observed with the adenovirus vaccine. Future adenovirus vaccine safety studies in a population without these co-administrations would be helpful in clarifying the vaccine’s safety profile.
Keywords	Adenoviridae ; anaphylaxis ; benzylpenicillin ; databases ; death ; Guillain-Barre Syndrome ; males ; medical records ; military personnel ; observational studies ; vaccination ; vaccines ; United States
Language	English
Dates of publication	2019-1016
Size	p. 6760-6767.
Publishing place	Elsevier Ltd
Document type	Article
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2019.08.087
Database	NAL-Catalogue (AGRICOLA)

Full text online

Accessible to users with ZB MED library card

In stock of ZB MED Cologne/Königswinter

Zs.A 1930: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 458: Show issues

Order via subito

Details ▾

To top

Full text online

More links

Kategorien

In stock of ZB MED Cologne/Königswinter

Order via subito

More links

Kategorien

Order via subito

Inter-library loan at ZB MED

Full text online

More links

Kategorien

In stock of ZB MED Cologne/Königswinter

Order via subito

More links

Kategorien

In stock of ZB MED Cologne/Königswinter

Order via subito

More links

Kategorien

Order via subito

More links

Kategorien

Order via subito

More links

Kategorien

Order via subito

Full text online

More links

Kategorien

In stock of ZB MED Cologne/Königswinter

Order via subito

Full text online

More links

Kategorien

In stock of ZB MED Cologne/Königswinter

Order via subito

Full text online

More links

Kategorien

In stock of ZB MED Cologne/Königswinter

Order via subito