PMID- 37539984
OWN - NLM
STAT- MEDLINE
DCOM- 20240219
LR  - 20240219
IS  - 1531-4995 (Electronic)
IS  - 0023-852X (Linking)
VI  - 134
IP  - 3
DP  - 2024 Mar
TI  - Otolaryngologic Side Effects After COVID-19 Vaccination.
PG  - 1163-1168
LID - 10.1002/lary.30923 [doi]
AB  - OBJECTIVES: With widespread vaccination against COVID-19, concerns regarding side 
      effects have been raised. We aim to assess the frequency of otolaryngologic 
      adverse events (AEs) following COVID-19 vaccination as compared with other 
      vaccines in a national database. STUDY DESIGN: Retrospective analysis of national 
      registry. METHODS: The Food and Drug Administration's Vaccine Adverse Event 
      Reporting System (VAERS) database was queried from December 2020 to May 2021 for 
      all COVID-19 vaccination AEs. Complaints were categorized as otolaryngologic and 
      sub stratified into different anatomic components. Reporting odds ratios (ROR) 
      and proportional reporting ratios (PRR) were determined for AEs of clinical 
      significance. RESULTS: The total number of AEs reported from vaccination with the 
      Moderna, Pfizer-BioNTech, and Janssen vaccines equaled 1,280,950. Of these, 
      62,660 (4.9%) were otolaryngologic in nature, with 32.6% associated with the 
      oropharynx/larynx, 18.3% with the nasal cavity/sinuses, 17.1% with the 
      ears/vestibular system, 10.0% with the oral cavity, and 21.9% miscellaneous. 
      Signal ratios reached significance levels for dysgeusia (n = 2124, PRR: 17.33, 
      ROR: 16.36), ageusia (n = 1376, PRR: 2.81, ROR: 2.81), anosmia (n = 983, PRR: 
      4.01, ROR: 4.01), rhinorrhea (n = 2203, PRR: 2.99, ROR: 3.00), throat tightness 
      (n = 3666, PRR: 4.99, ROR: 5.00), throat irritation (n = 3313, PRR: 4.51, ROR: 
      4.52), dysphagia (n = 2538, PRR: 2.07, ROR: 2.07), tinnitus (n = 4377, PRR: 3.97, 
      ROR: 3.98), and vertigo (n = 2887, PRR: 3.93, ROR: 3.93). Signal ratios were not 
      significant for facial paralysis, Bell's palsy, anaphylaxis, sinusitis, hearing 
      disability, and ear pain. CONCLUSIONS: Although several otolaryngologic symptoms 
      were reported, few were found to be clinically significant. Of note, facial 
      paralysis, Bell's palsy, and anaphylaxis did not meet signal thresholds to be 
      determined significant. LEVEL OF EVIDENCE: 4 Laryngoscope, 134:1163-1168, 2024.
CI  - (c) 2023 The American Laryngological, Rhinological and Otological Society, Inc.
FAU - Ahsanuddin, Salma
AU  - Ahsanuddin S
AUID- ORCID: 0000-0002-9081-2832
AD  - Department of Otorhinolaryngology - Head and Neck Surgery, Albert Einstein 
      College of Medicine, Montefiore Medical Center, Bronx, New York, USA.
FAU - Jin, Ryan
AU  - Jin R
AUID- ORCID: 0000-0001-6244-8175
AD  - Department of Otolaryngology-Head & Neck Surgery, Rutgers New Jersey Medical 
      School, Newark, New Jersey, USA.
FAU - Dhanda, Aatin K
AU  - Dhanda AK
AUID- ORCID: 0000-0002-8926-7662
AD  - Department of Otolaryngology-Head & Neck Surgery, Rutgers New Jersey Medical 
      School, Newark, New Jersey, USA.
FAU - Georges, Kirolos
AU  - Georges K
AUID- ORCID: 0000-0002-0637-5036
AD  - Department of Otolaryngology-Head & Neck Surgery, Rutgers New Jersey Medical 
      School, Newark, New Jersey, USA.
FAU - Baredes, Soly
AU  - Baredes S
AD  - Department of Otolaryngology-Head & Neck Surgery, Rutgers New Jersey Medical 
      School, Newark, New Jersey, USA.
FAU - Eloy, Jean Anderson
AU  - Eloy JA
AUID- ORCID: 0000-0003-2893-7818
AD  - Department of Otolaryngology-Head & Neck Surgery, Rutgers New Jersey Medical 
      School, Newark, New Jersey, USA.
AD  - Center for Skull Base and Pituitary Surgery, Neurological Institute of New 
      Jersey, Rutgers New Jersey Medical School, Newark, New Jersey, USA.
AD  - Department of Neurological Surgery, Rutgers New Jersey Medical School, Newark, 
      New Jersey, USA.
AD  - Department of Ophthalmology and Visual Science, Rutgers New Jersey Medical 
      School, Newark, New Jersey, USA.
AD  - Department of Otolaryngology and Facial Plastic Surgery, Saint Barnabas Medical 
      Center, RWJBarnabas Health, Livingston, New Jersey, USA.
FAU - Fang, Christina H
AU  - Fang CH
AUID- ORCID: 0000-0001-6047-2788
AD  - Department of Otorhinolaryngology - Head and Neck Surgery, Albert Einstein 
      College of Medicine, Montefiore Medical Center, Bronx, New York, USA.
LA  - eng
PT  - Journal Article
DEP - 20230804
PL  - United States
TA  - Laryngoscope
JT  - The Laryngoscope
JID - 8607378
RN  - 0 (COVID-19 Vaccines)
RN  - 0 (Vaccines)
SB  - IM
MH  - Humans
MH  - COVID-19 Vaccines/adverse effects
MH  - *Anaphylaxis/chemically induced
MH  - *Bell Palsy/chemically induced
MH  - *Facial Paralysis/chemically induced
MH  - Pharynx
MH  - Retrospective Studies
MH  - Adverse Drug Reaction Reporting Systems
MH  - *COVID-19/epidemiology/prevention & control
MH  - *Vaccines/adverse effects
MH  - Vaccination
OTO - NOTNLM
OT  - COVID-19
OT  - adverse events
OT  - otolaryngology
OT  - pharmacovigilance
OT  - vaccination
EDAT- 2023/08/04 13:10
MHDA- 2024/02/19 06:43
CRDT- 2023/08/04 08:33
PHST- 2023/07/11 00:00 [revised]
PHST- 2022/12/19 00:00 [received]
PHST- 2023/07/13 00:00 [accepted]
PHST- 2024/02/19 06:43 [medline]
PHST- 2023/08/04 13:10 [pubmed]
PHST- 2023/08/04 08:33 [entrez]
AID - 10.1002/lary.30923 [doi]
PST - ppublish
SO  - Laryngoscope. 2024 Mar;134(3):1163-1168. doi: 10.1002/lary.30923. Epub 2023 Aug 
      4.