Facial nerve palsy including Bell's palsy: Case definitions and guidelines for collection, analysis, and presentation of immunisation safety data

Rath, Barbara; Gidudu, Jane; Anyoti, Helen; Bollweg, Brigid C.; Caubel, Patrick; Chen, Yeoung-Hwang; Cornblath, David; Fernandopulle, Rohini; Fries, Louis; Galama, J.M.D.; Gibbs, Neville A.; Grilli, G; Patrick, Grogan; Hartmann, Katharina; Heininger, Ulrich; Hudson, Michael J.; Izurieta, Héctor S.; Jevaji, Indira; Johnson, Wiltshire M.; Jones, James F.; Keller‐Stanislawski, Brigitte; Klein, Jerome O.; Kohl, Katrin; Kokotis, Panagiotis; Li, Yulin; Linder, Thomas; Oleske, James M.; Richard, Georgina; Shafshak, Tarek S.; Vajdy, Michael; Wong, Virginia; Sejvar, James J.

doi:10.1016/j.vaccine.2016.05.023

Cited by 37 publications

(28 citation statements)

References 137 publications

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“…In light of the above findings, we intended to determine whether a current analysis of the VAERS database for reports of facial paralysis over the past 5 years would reveal a signal and describe the clinical characteristics of the cases. In order to account for the different types of influenza vaccines available and the difficulties involved in identifying Bell’s palsy from a user-reported passive surveillance system [ 23 ], in our study, we included reports of facial paralysis following vaccination with any of the currently marketed influenza vaccine.…”

Section: Introductionmentioning

confidence: 99%

Facial Paralysis Following Influenza Vaccination: A Disproportionality Analysis Using the Vaccine Adverse Event Reporting System Database

2020

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Background and Objective Several cases of facial paralysis have been reported following influenza vaccination; however, recent surveillance studies have not shown an increased risk. In this study, we analyzed the vaccine adverse event reporting system (VAERS) data to determine whether the facial paralysis reporting rate is higher in those who received influenza vaccination compared with those who received other vaccines. Methods We evaluated reports of facial paralysis in people who received influenza vaccination during January 2015 to October 2019 using Medical Dictionary for Regulatory Activities Preferred Terms. A disproportionality analysis was performed to determine the proportional reporting ratio (PRR), Chi-square statistic, and reporting odds ratio (ROR) with 95% confidence interval (CI). The demographic and clinical characteristics of the cases were also analyzed. Results Two hundred fifty cases of facial paralysis following influenza vaccination were reported during the study period. The median age of the patients was 45 (interquartile range, 30-57) years; 132 (52.8%) patients were females. The majority of the patients received the injected trivalent or quadrivalent seasonal influenza vaccine by intramuscular route. The PRR, Chi-square statistic, and ROR (95% CI) was 2.44, 122.32, and 2.44 (2.08-2.88), respectively; on excluding cases involving concomitant paresis/paralysis of limbs or Guillain-Barre syndrome, the disproportionality statistics were 2.30, 89.37, and 2.30 (1.93-2.75), respectively. Conclusions Our study shows increased reporting of facial paralysis following influenza vaccination as compared with other vaccines. Considering the inherent limitations of the VAERS database analysis, and the fact that disproportionality measures only indicate the presence of a signal, our study findings need to be explored in well-designed prospective pharmacoepidemiologic studies.

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Section: Introductionmentioning

confidence: 99%

Facial Paralysis Following Influenza Vaccination: A Disproportionality Analysis Using the Vaccine Adverse Event Reporting System Database

2020

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“…When Bell's palsy is suspected, the idiopathic nature of the disease will need to reveal itself over time [60]. The current definition requires ''resolution of symptoms'' as a mandatory criterion [60]. In the present study, only one patient with peripheral facial nerve palsy was hospitalized long enough for the cranial nerve deficit to resolve completely.…”

Section: Discussionmentioning

confidence: 81%

“…Similarly, Guillain-Barré and Fisher syndrome require repeated assessments prior to classification [26]. When Bell's palsy is suspected, the idiopathic nature of the disease will need to reveal itself over time [60]. The current definition requires ''resolution of symptoms'' as a mandatory criterion [60].…”

Section: Discussionmentioning

confidence: 99%

Innovative Digital Tools and Surveillance Systems for the Timely Detection of Adverse Events at the Point of Care: A Proof-of-Concept Study

et al. 2016

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“…According to the patient's facial function damage, selecting different meridian points can purposely affect the facial meridians. Modern studies have also suggested that the occurrence of facial paralysis may be related to weakened immunity [13,20]. Although the onset is regardless of age and gender, a North American study suggests that children have a higher incidence of Bell's palsy [21].…”

Section: Introductionmentioning

confidence: 99%

Should acupuncture therapy be used for acute facial paralysis? A protocol of systematic review

Cheng¹,

Li²,

Yang³

et al. 2021

Preprint

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Introduction Peripheral Facial paralysis (PFP) results in functional and social dysfunction, when it is under a severe condition at onset, long-term poor outcomes do occur. Different acupuncture method has been reported to be potentially effective for shortening the disease course and reduce the occurrence of sequelae when applying at an early stage. Neuroedema is a common pathological feature in the acute phase, many clinical studies have suggested its effect of reducing facial nerve edema. It is of value to estimate the effectiveness and safety of acupuncture treatment at the onset, and it is worthwhile to assess the most suitable acupuncture method for the acute period. Methods and analysis We will include all the RCTs and quasi-RCTs on acupuncture therapy for PFP at its acute stage. Literature searching will be conducted until September 15th, 2020 from eight databases systematically. Two reviewers will screen the literature and extract the data independently. RevMan software and the Cochrane tool of Risk of Bias will be used to assess the methodological quality of RCTs. Forest plots and summary findings will be generated. If data permits, a meta-analysis will be conducted. Ethics and dissemination Since this study will not involve clinical treatment of patients, ethics approval is not required. The result of this study will be submitted to a peer-reviewed journal for publication and as a proposal for clinical practice and further study on acupuncture treatment at the early stage of PFP. Discussion This review will summarize the evidence on the different type of acupuncture therapy for acute bell’s palsy and Ramsay-Hunt syndrome. We anticipate that it would be safe and effective when applying to the acute phase of PFP, and some specific suitable acupuncture methods would be found resulting from this review.Trial registration number International Prospective Register for Systematic Reviews (PROSPERO) number CRD42020205127

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Facial nerve palsy including Bell's palsy: Case definitions and guidelines for collection, analysis, and presentation of immunisation safety data

Cited by 37 publications

References 137 publications

Facial Paralysis Following Influenza Vaccination: A Disproportionality Analysis Using the Vaccine Adverse Event Reporting System Database

Facial Paralysis Following Influenza Vaccination: A Disproportionality Analysis Using the Vaccine Adverse Event Reporting System Database

Innovative Digital Tools and Surveillance Systems for the Timely Detection of Adverse Events at the Point of Care: A Proof-of-Concept Study

Should acupuncture therapy be used for acute facial paralysis? A protocol of systematic review

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