Motor palsies of cranial nerves (excluding VII) after vaccination: reports to the US Vaccine Adverse Event Reporting System.
We reviewed cranial nerve palsies, other than VII, that have been reported to the US Vaccine Adverse Event Reporting System (VAERS). We examined patterns for differences in vaccine types, seriousness, age, and clinical characteristics. We identified 68 reports of cranial nerve palsies, most commonly involving the oculomotor (III), trochlear (IV), and abducens (VI) nerves. Isolated cranial nerve palsies, as well as palsies occurring as part of a broader clinical entity, were reported. Forty reports (59%) were classified as serious, suggesting that a cranial nerve palsy may sometimes be the harbinger of a broader and more ominous clinical entity, such as a stroke or encephalomyelitis. There was no conspicuous clustering of live vs. inactivated vaccines. The patient age range spanned the spectrum from infants to the elderly. Independent data may help to clarify whether, when, and to what extent the rates of cranial nerve palsies following particular vaccines may exceed background levels.
Office of Biostatistics and Epidemiology; Center for Biologics Evaluation and Research; US Food and Drug Administration; Rockville, MD USA.
Emily Jane
EJ
Woo
Office of Biostatistics and Epidemiology; Center for Biologics Evaluation and Research; US Food and Drug Administration; Rockville, MD USA.
Scott K
SK
Winiecki
Division of Microbiology and Infectious Diseases; National Institutes of Allergy and Immunological Disorders; National Institutes of Health; Bethesda, MD USA.
Alan C
AC
Ou
D000293:Adolescent; D000328:Adult; D017677:Age Distribution; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D003391:Cranial Nerves / Q000187:drug effects*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000473:pathology; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D010243:Paralysis / Q000139:chemically induced* / Q000453:epidemiology* / Q000473:pathology; D012307:Risk Factors; D014481:United States / Q000453:epidemiology; D014611:Vaccination / Q000009:adverse effects*; D014612:Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D055815:Young Adult
D014612:Vaccines
adverse event; cranial nerve palsy; disconjugate gaze; postmarketing safety surveillance; ptosis; vaccine