PMID- 35198288
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220225
IS  - 2168-8184 (Print)
IS  - 2168-8184 (Electronic)
IS  - 2168-8184 (Linking)
VI  - 14
IP  - 1
DP  - 2022 Jan
TI  - Analysis of Neurological Adverse Events Reported in VigiBase From COVID-19 
      Vaccines.
PG  - e21376
LID - 10.7759/cureus.21376 [doi]
LID - e21376
AB  - BACKGROUND: Fifteen COVID-19 vaccines have been granted emergency approval before 
      the completion of conventional phases of clinical trials. The present study aimed 
      to analyze the neurological adverse events (AEs) post-COVID-19 vaccination and 
      focuses on determining the association of AEs with the vaccine. METHODOLOGY: The 
      neurological AEs reported for COVID-19 vaccines in the WHO pharmacovigilance 
      database (VigiBase) were extracted from the System Organ Classes - neurological 
      disorders and investigations. Descriptive statistics are reported as percentage 
      and frequency and the disproportionality analysis was also conducted. RESULTS: 
       For the neurological system, 19,529 AEs were reported. Of these, 15,638 events 
      were reported from BNT162b2 vaccine, 2,751 from AZD1222 vaccine, 1,075 from 
      mRNA-1273 vaccine, eight from Vero vaccine, two from Covaxin, and for 55 AEs, 
      vaccine name was not mentioned. The reason for more AEs reported with BNT162b2 
      can be maximum vaccination with BNT162b2 vaccine in the study period. According 
      to the disproportionality analysis based on IC(025) value, ageusia, anosmia, 
      burning sensation, dizziness, facial paralysis, headache, hypoaesthesia, 
      lethargy, migraine, neuralgia, paresis, parosmia, poor sleep quality, seizure, 
      transient ischemic attack, and tremor are some of the AEs that can be associated 
      with the administration of the vaccine. CONCLUSION: The vaccines should be 
      monitored for these AEs till the causality of these AEs with COVID-19 vaccines is 
      established through further long-term follow-up studies. These neurological AEs 
      reported in VigiBase should not be taken as conclusive and mass vaccination 
      should be carried out to control the pandemic until a definite link of these 
      adverse effects is established.
CI  - Copyright (c) 2022, Dutta et al.
FAU - Dutta, Siddhartha
AU  - Dutta S
AD  - Department of Pharmacology, All India Institute of Medical Sciences, Rajkot, 
      Rajkot, IND.
FAU - Kaur, Rimplejeet
AU  - Kaur R
AD  - Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur, 
      Jodhpur, IND.
FAU - Charan, Jaykaran
AU  - Charan J
AD  - Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur, 
      Jodhpur, IND.
FAU - Bhardwaj, Pankaj
AU  - Bhardwaj P
AD  - Department of Community Medicine & Family Medicine and School of Public Health, 
      All India Institute of Medical Sciences, Jodhpur, Jodhpur, IND.
FAU - Ambwani, Sneha R
AU  - Ambwani SR
AD  - Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur, 
      Jodhpur, IND.
FAU - Babu, Shoban
AU  - Babu S
AD  - Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur, 
      Jodhpur, IND.
FAU - Goyal, Jagdish P
AU  - Goyal JP
AD  - Department of Pediatrics, All India Institute of Medical Sciences, Jodhpur, 
      Jodhpur, IND.
FAU - Haque, Mainul
AU  - Haque M
AD  - Department of Pharmacology and Therapeutics, National Defence University of 
      Malaysia, Kuala Lumpur, MYS.
LA  - eng
PT  - Journal Article
DEP - 20220118
PL  - United States
TA  - Cureus
JT  - Cureus
JID - 101596737
PMC - PMC8852793
OTO - NOTNLM
OT  - adverse events
OT  - adverse events following immunization
OT  - azd1222
OT  - bnt162b2
OT  - covid-19 vaccines
OT  - mrna-1273
OT  - neurological disorders
OT  - sars-cov-2 (severe acute respiratory syndrome coronavirus -2)
COIS- The authors have declared that no competing interests exist.
EDAT- 2022/02/25 06:00
MHDA- 2022/02/25 06:01
PMCR- 2022/01/18
CRDT- 2022/02/24 05:42
PHST- 2022/01/18 00:00 [accepted]
PHST- 2022/02/24 05:42 [entrez]
PHST- 2022/02/25 06:00 [pubmed]
PHST- 2022/02/25 06:01 [medline]
PHST- 2022/01/18 00:00 [pmc-release]
AID - 10.7759/cureus.21376 [doi]
PST - epublish
SO  - Cureus. 2022 Jan 18;14(1):e21376. doi: 10.7759/cureus.21376. eCollection 2022 
      Jan.