scholarly journals Guillain-Barré Syndrome after COVID-19 Vaccination in the Vaccine Safety Datalink

2021 ◽  
Author(s):  
Kayla E. Hanson ◽  
Kristin Goddard ◽  
Ned Lewis ◽  
Bruce Fireman ◽  
Tanya R. Myers ◽  
...  
Keyword(s):  
Incidence Rate ◽  
Interim Analysis ◽  
Large Population ◽  
Vaccine Safety ◽  
The United States ◽  
Surveillance Data ◽  
Guillain Barre Syndrome ◽  
Background Rate ◽  
Guillain Barré Syndrome ◽  
Guillain Barré

AbstractImportancePost-authorization monitoring of vaccines in a large population can detect rare adverse events not identified in clinical trials including Guillain-Barré syndrome (GBS). GBS has a background rate of 1-2 per 100,000 person-years.ObjectiveTo 1) describe cases and incidence of GBS following COVID-19 vaccination, and 2) assess the risk of GBS after vaccination for Ad.26.COV2.S (Janssen) and mRNA vaccines.DesignInterim analysis of surveillance data from the Vaccine Safety Datalink.SettingEight participating integrated healthcare systems in the United States.Participants10,158,003 individuals aged ≥12 years.ExposuresReceipt of Ad.26.COV2.S, BNT162b2 (Pfizer-BioNTech), or mRNA-1273 (Moderna) COVID-19 vaccine.Main Outcomes and MeasuresGBS with symptom onset in the 1-84 days after vaccination as confirmed by medical record review and adjudication. Descriptive characteristics of confirmed cases, GBS incidence rates during postvaccination risk intervals after each type of vaccine compared to the background rate, rate ratios (RRs) comparing GBS incidence in the 1-21 vs. 22-42 days postvaccination, and RRs directly comparing risk of GBS after Ad.26.COV2.S vs. mRNA vaccination, using Poisson regression adjusted for age, sex, race/ethnicity, site, and calendar day.ResultsFrom December 13, 2020 through November 13, 2021, 14,723,318 doses of COVID-19 vaccines were administered, including 467,126 Ad.26.COV2.S, 8,573,823 BNT162b2, and 5,682,369 mRNA-1273 doses. Eleven cases of GBS after Ad.26.COV2.S were confirmed. The unadjusted incidence rate of confirmed cases of GBS per 100,000 person-years in the 1-21 days after Ad.26.COV2.S was 34.6 (95% confidence interval [CI]: 15.8-65.7), significantly higher than the background rate, and the adjusted RR in the 1-21 vs. 22-42 days following Ad.26.COV2.S was 6.03 (95% CI: 0.79-147.79). Thirty-four cases of GBS after mRNA vaccines were confirmed. The unadjusted incidence rate of confirmed cases per 100,000 person-years in the 1-21 days after mRNA vaccines was 1.4 (95% CI: 0.7-2.5) and the adjusted RR in the 1-21 vs. 22-42 days following mRNA vaccines was 0.56 (95% CI: 0.21-1.48). In a head-to-head comparison of Ad.26.COV2.S vs. mRNA vaccines, the adjusted RR was 20.56 (95% CI: 6.94-64.66).Conclusions and RelevanceIn this interim analysis of surveillance data of COVID-19 vaccines, the incidence of GBS was elevated after Ad.26.COV2.S. Surveillance is ongoing.

scholarly journals Guillain-Barré Syndrome After High-Dose Influenza Vaccine Administration in the United States, 2018–2019 Season

2020 ◽  
Author(s):  
Silvia Perez-Vilar ◽  
Mao Hu ◽  
Eric Weintraub ◽  
Deepa Arya ◽  
Bradley Lufkin ◽  
...  
Keyword(s):  
Influenza Vaccine ◽  
Vaccine Safety ◽  
The United States ◽  
Guillain Barre Syndrome ◽  
High Dose ◽  
Medicare Beneficiaries ◽  
Increased Risk ◽  
Guillain Barré Syndrome ◽  
Control Window ◽  
Guillain Barré

Abstract Background The Vaccine Safety Datalink (VSD) identified a statistical signal for an increased risk of Guillain-Barré syndrome (GBS) in days 1–42 after 2018–2019 high-dose influenza vaccine (IIV3-HD) administration. We evaluated the signal using Medicare. Methods We conducted early- and end-of-season claims-based self-controlled risk interval analyses among Medicare beneficiaries ages ≥65 years, using days 8–21 and 1–42 postvaccination as risk windows and days 43–84 as control window. The VSD conducted chart-confirmed analyses. Results Among 7 453 690 IIV3-HD vaccinations, we did not detect a statistically significant increased GBS risk for either the 8- to 21-day (odds ratio [OR], 1.85; 95% confidence interval [CI], 0.99–3.44) or 1- to 42-day (OR, 1.31; 95% CI, 0.78–2.18) risk windows. The findings from the end-of-season analyses were fully consistent with the early-season analyses for both the 8- to 21-day (OR, 1.64; 95% CI, 0.92–2.91) and 1- to 42-day (OR, 1.12; 95% CI, 0.70–1.79) risk windows. The VSD’s chart-confirmed analysis, involving 646 996 IIV3-HD vaccinations, with 1 case each in the risk and control windows, yielded a relative risk of 1.00 (95% CI, 0.06–15.99). Conclusions The Medicare analyses did not exclude an association between IIV3-HD and GBS, but it determined that, if such a risk existed, it was similar in magnitude to prior seasons. Chart-confirmed VSD results did not confirm an increased risk of GBS.

Estimation of the Probability That Guillain-Barre Syndrome was Caused by the Swine Flu Vaccine: US Experience (1976–77)

1984 ◽  
Vol 24 (1) ◽  
pp. 61-67 ◽  
Author(s):  
Richard L. Greenstreet
Keyword(s):  
United States ◽  
Puerto Rico ◽  
New Jersey ◽  
Statistical Method ◽  
The United States ◽  
Guillain Barre Syndrome ◽  
Swine Flu ◽  
Guillain Barré Syndrome ◽  
Flu Vaccine ◽  
Guillain Barré

A statistical method was presented for determining the probability that cases of Guillain-Barre syndrome (GBS) among residents of the United States and Puerto Rico who participated in the 1976–77 swine flu vaccine programme were due to the vaccine. It was determined that the vaccine (A/New Jersey) was the most likely cause of GBS if the onset was within five weeks after vaccination. From the sixth to the tenth week after vaccination, the association was unlikely. After the tenth week, the association between the vaccine and GBS was negative.

Gastrointestinal Tract Infections

2017 ◽  
Author(s):  
Marcia B Goldberg ◽  
Molly Paras
Keyword(s):  
Escherichia Coli ◽  
Shiga Toxin ◽  
Reactive Arthritis ◽  
The United States ◽  
Etiologic Agent ◽  
Guillain Barre Syndrome ◽  
Gastrointestinal Infections ◽  
Guillain Barré Syndrome ◽  
Guillain Barré ◽  
Tract Infections

Gastrointestinal infections, which present with acute diarrhea, sometimes accompanied by vomiting, are an extremely common medical complaint, with an annual incidence of 0.6 illnesses per person. Transmission can occur from animals to person, from person to person, or by the ingestion of contaminated foodstuffs. In the United States, more than 90% of cases are caused by viruses, with norovirus being by far the most common. Common among bacterial causes of acute gastrointestinal infection are Salmonella, Campylobacter, Shigella, Shiga toxin–producing Escherichia coli, Vibrio, Yersinia, and Clostridium difficile. These infections are typically self-limited, but depending on the etiologic agent and characteristics of the host, antibiotic therapy may be indicated. Certain gastrointestinal infections are associated with significant complications, including reactive arthritis, Guillain-Barré syndrome, or septicemia. This review contains 4 figures, 7 tables, and 60 references. Key words: Campylobacter, Escherichia coli, Guillain-Barré syndrome, reactive arthritis, Shiga toxin, Shigella, Vibrio, Yersinia

scholarly journals Estimation of the Incidence of Guillain-Barré Syndrome During Pregnancy in the United States

2019 ◽  
Vol 6 (3) ◽  
Author(s):  
Tanya R Myers ◽  
Natalie L McCarthy ◽  
Lakshmi Panagiotakopoulos ◽  
Saad B Omer
Keyword(s):  
United States ◽  
Adverse Event ◽  
Confidence Interval ◽  
The United States ◽  
Guillain Barre Syndrome ◽  
Rare Occurrence ◽  
Guillain Barré Syndrome ◽  
Safety Assessments ◽  
Few Data ◽  
Guillain Barré

Abstract Guillain-Barré syndrome (GBS) is an adverse event of interest after vaccination, yet few data are available for background rates during pregnancy. We confirmed 2 cases of incident GBS and estimated an incidence of 2.8 confirmed GBS cases per million person-years (95% confidence interval, 0.5–9.3), indicating rare occurrence. Our findings will help inform safety assessments of Zika vaccines in pregnant populations.

scholarly journals Nonlinear Analysis of Guillain Barré Time Series to Elucidate Its Epidemiology

2013 ◽  
Vol 2013 ◽  
pp. 1-5
Author(s):  
Zurina Lestayo O'Farrill ◽  
José Luís Hernández Cáceres ◽  
Esperanza O'Farrill Mons
Keyword(s):  
Time Series ◽  
Incidence Rate ◽  
Guillain Barre Syndrome ◽  
Guillain Barré Syndrome ◽  
Annual Periodicity ◽  
Point Attractor ◽  
Identification Approach ◽  
Low Incidence ◽  
Statistical Time ◽  
Guillain Barré

The etiology of Guillain Barré Syndrome (GBS) is not fully clarified, and there is a lack of agreement concerning its putative epidemic character. The low incidence rate of this disease is a disadvantage for employing the traditional statistical methods used in the analysis of epidemics. The objective of this paper is to clarify the GBS epidemic behavior applying a nonlinear time series identification approach. The authors obtained one time series of GBS and nine series of classical infectious epidemics (5 national and 4 international). These data were processed with advanced techniques of statistical time series analysis. This paper shows that GBS behaves similar to the other time series of classical epidemic studied. It corresponds to a nonlinear dynamics, with a point attractor. The spectral analysis pointed to an annual periodicity, and preference for the warmest month of the year was found. These results might suggest that Guillain Barré Syndrome has an epidemic behavior. The adequacy of nonlinear methods for analyzing the dynamics of epidemics, particularly those with low incidence rate, such as GBS was revealed.

Campylobacter jejuni Infection during Pregnancy: Long-Term Consequences of Associated Bacteremia, Guillain-Barré Syndrome, and Reactive Arthritis†

2002 ◽  
Vol 65 (4) ◽  
pp. 696-708 ◽  
Author(s):  
JAMES L. SMITH
Keyword(s):  
Pregnant Women ◽  
Campylobacter Jejuni ◽  
Reactive Arthritis ◽  
The United States ◽  
Guillain Barre Syndrome ◽  
Normal Infant ◽  
Guillain Barré Syndrome ◽  
Long Term Consequences ◽  
Guillain Barré

Campylobacter jejuni infections are the main cause of foodborne gastroenteritis in the United States and other developed countries. Generally, C. jejuni infections are self-limiting and treatment is not necessary; however, infections caused by this organism can lead to potentially dangerous long-term consequences for some individuals. Bacteremia, Guillain-Barré syndrome (GBS; an acute flaccid paralytic disease), and reactive arthritis (ReA) are the most serious of the long-term consequences of C. jejuni infections. During pregnancy, foodborne infections may be hazardous to both the woman and the fetus. C. jejuni–induced bacteremia during pregnancy may lead to intrauterine infection of the fetus, abortion, stillbirth, or early neonatal death. Infection of a newborn by the mother during the birth process or shortly after birth may lead to neonatal enteritis, bacteremia, and/or meningitis. C. jejuni enteritis is the inducing antecedent infection in approximately 30% of cases of GBS. Thus, pregnant women infected with C. jejuni may contract GBS. GBS during pregnancy does not affect fetal or infant development and does not increase spontaneous abortion or fetal death; however, it may induce spontaneous delivery during the third trimester in severe cases. Reactive arthritis occurs in approximately 2% of C. jejuni enteritis cases and leads to the impaired movement of various joints. Pregnant women with C. jejuni–induced reactive arthritis can be expected to deliver a normal infant. A pregnant patient with GBS or ReA may be unable to care for a newborn infant because of the physical impairment induced by these diseases. Since C. jejuni infections put both fetuses and pregnant women at risk, pregnant women must take special care in food handling and preparation to prevent such infections.

Arthritis, Guillain-Barré Syndrome, and Other Sequelae of Campylobacter jejuni Enteritis†

1995 ◽  
Vol 58 (10) ◽  
pp. 1153-1170 ◽  
Author(s):  
JAMES L. SMITH
Keyword(s):  
United States ◽  
Campylobacter Jejuni ◽  
Circulatory System ◽  
Developed Countries ◽  
The United States ◽  
Guillain Barre Syndrome ◽  
Food Sources ◽  
Fisher Syndrome ◽  
Guillain Barré Syndrome ◽  
Guillain Barré

The most frequently identified cause of gastroenteritis in developed countries is Campylobacter jejuni. In the United States, dairy products are the food sources commonly associated with outbreaks; however, most cases of C. jejuni gastroenteritis are sporadic, with poultry as the major source. Diarrhea, malaise, fever, and abdominal pain are the usual symptoms of C. jejuni enteritis. Lasting only a few days, the illness is generally self-limiting; however, some cases may be more severe. Although several virulence factors have been identified in C. jejuni, their role in disease is currently unclear. C. jejuni has been linked to the acquisition of certain forms of sterile arthritides such as reactive arthritis and Reiter's syndrome and to acute generalized paralytic diseases such as Guillain-Barré syndrome, Miller-Fisher syndrome, and Chinese paralytic syndrome. In addition, C. jejuni may induce diseases affecting the nervous system, circulatory system, and various organs, particularly in immunocompromised individuals. Illnesses associated with C. jejuni have been estimated to cost the citizens of the United States several billion dollars annually.

scholarly journals Active pharmacovigilance of the seasonal trivalent influenza vaccine produced by Instituto Butantan: A prospective cohort study of five target groups

PLoS ONE ◽  
2021 ◽  
Vol 16 (2) ◽  
pp. e0246540
Author(s):  
Tazio Vanni ◽  
Beatriz da Costa Thomé ◽  
Mayra Martho Moura de Oliveira ◽  
Vera Lúcia Gattás ◽  
Maria da Graça Salomão ◽  
...  
Keyword(s):  
Adverse Events ◽  
Pregnant Women ◽  
Prospective Cohort ◽  
Healthcare Workers ◽  
Vaccine Safety ◽  
Median Number ◽  
Influenza Vaccines ◽  
Guillain Barre Syndrome ◽  
Guillain Barré Syndrome ◽  
Guillain Barré

Introduction Active pharmacovigilance studies are pivotal to better characterize vaccine safety. Methods These are multicenter prospective cohort studies to evaluate the safety of the 2017 and 2018 seasonal trivalent influenza vaccines (TIVs) manufactured by Instituto Butantan, by means of active pharmacovigilance practices. Elderly, children, healthcare workers, pregnant women, and women in the puerperium period were invited to participate in the study during the 2017 and 2018 Brazilian national seasonal influenza vaccination campaigns. Following immunization, participants were observed for 30 minutes and they received a participant card to register adverse events information. All safety information registered were checked at a clinical site visit 14 days after immunization and by a telephone contact 42 days after immunization for unsolicited Adverse Events (AE) and Guillain-Barré Syndrome (GBS). Results A total of 942 volunteers participated in the two studies: 305 elderly, 109 children, 108 pregnant women, 32 women in the postpartum period, and 388 health workers. Overall, the median number of AR per participant ranged from 1 to 4. The lowest median number of AR per participant was observed among healthcare workers (1 AR per participant) and the highest among pregnant women (4 AR per participant). Overall, local pain (46.6%) was the most frequent solicited local AR. The most frequent systemic ARs were: headache (22.5%) followed by fatigue (16.0%), and malaise (11.0%). The majority of solicited ARs (96%) were mild, Grades 1 or 2), only 3% were Grade 3, and 1% was Grade 4. No serious AEs, including Guillain-Barré Syndrome, were reported up to 42 days postvaccination. Conclusion The results from the two studies confirmed that the 2017 and 2018 seasonal trivalent influenza vaccines produced by Instituto Butantan were safe and that active pharmacovigilance studies should be considered, when it is feasible, as an important initiative to monitor vaccine safety in the post-marketing period.

Sign in / Sign up

Export Citation Format

Share Document