scholarly journals “Prepandemic” Immunization for Novel Influenza Viruses, “Swine Flu” Vaccine, Guillain‐Barré Syndrome, and the Detection of Rare Severe Adverse Events

2009 ◽  
Vol 200 (3) ◽  
pp. 321-328 ◽  
Author(s):  
David Evans ◽  
Simon Cauchemez ◽  
Frederick G Hayden
1984 ◽  
Vol 24 (1) ◽  
pp. 61-67 ◽  
Author(s):  
Richard L. Greenstreet

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.


Neurology ◽  
1986 ◽  
pp. 249-254
Author(s):  
L. T. Kurland ◽  
W. C. Wiederholt ◽  
E. Beghi ◽  
J. W. Kirkpatrick ◽  
H. G. Potter ◽  
...  

1999 ◽  
Vol 23 (6) ◽  
pp. 619-647 ◽  
Author(s):  
D. A. Freedman ◽  
Philip B. Stark

2019 ◽  
Vol 12 (8) ◽  
pp. e230848 ◽  
Author(s):  
Julien Pierrard ◽  
Bénédicte Petit ◽  
Sarah Lejeune ◽  
Emmanuel Seront

The increased use of immune checkpoint inhibitors (ICIs) has led to the observation of a variety of immune-related adverse events (irAEs). These irAEs occur usually within the first months after ICIs onset and can involve theorically all organs. We describe two rare irAEs occurring in a 70-year-old caucasian man who was treated with nivolumab for an advanced urothelial cancer of the left kidney. He developed an isolated adrenocorticotropic hormone deficiency that was diagnosed at week 19 and a neurological complication that appeared at week 79 and initially confounded with a lumbar spinal stenosis. Diagnosis of Guillain-Barré syndrome was finally confirmed with the complete resolution of symptoms after 5 days of intravenous immunoglobulin and corticosteroids. We highlight the importance of quickly recognising these potential life-threatening irAEs such as cortisol insufficiency and neurologic adverse events whose initially presentation could be non-specific.


2021 ◽  
Author(s):  
Yang Sun ◽  
Yanjun Guo ◽  
Yaqing Wu ◽  
Ningning Luo ◽  
Xinjia He

Abstract Immunotherapy combinations have changed the treatment paradigm of advanced renal cell carcinoma (RCC). Notably, immunotherapy induces a new spectrum of immune-related adverse events (irAEs). Guillain–Barré syndrome (GBS) is a rare and potentially fatal nervous system irAE. The activation of T-cell is considered a triggering factor of GBS. We herein reported a case of GBS-like syndrome during treatment of tislelizumab and axitinib in a patient with RCC. To our knowledge, this is the first report of tislelizumab-related GBS.


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 ◽  
...  

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.


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