Paresthesia and sensory disturbances associated with 2009 pandemic vaccine receipt: Clinical features and risk factors

Vaccine. 2015 Aug 26;33(36):4464-71. doi: 10.1016/j.vaccine.2015.07.028. Epub 2015 Jul 22.

Abstract

Background: Paresthesia was the third-most-common adverse event following immunization (AEFI) with 2009 monovalent AS03-adjuvanted A(H1N1)pdm09 vaccine in Quebec, Canada and was also frequently reported in Europe. This study assessed clinical features and risk factors associated with this unexpected AEFI.

Methods: Reports to the passive surveillance system were summarized. A case-control study was conducted to assess risk factors and additional investigations were undertaken among cases with symptoms persisting ≥12 months.

Results: There were 328 reports of paresthesia affecting the vaccinated arm (58%), but also face (45%), lower limbs (40%) and back/thorax (23%) with numbness but also muscle weakness (61%), motor impairment (61%), generalized myalgia (37%), visual (14%) and/or speech effects (15%). Reporting rate was highest in women of reproductive age, peaking at 30-39 years-old (28/100,000 doses administered) and exceeding that of men of the same age (7/100,000 doses) by 4-fold. Median time to onset was 2h. Symptoms subsided within one week in 37% but lasted ≥6 months in 26%. No consistent or objective neurological findings were identified. Risk was increased with allergy history, respiratory illness the day of vaccination, depressive symptoms and family history of pulmonary disease, but decreased with physical activity the day of vaccination, and regular weekly alcohol consumption.

Conclusion: Paresthesia following 2009 pandemic vaccine receipt lasted several weeks and included other motor-sensory disturbances in an important subset of patients. Although it does not correspond with known neurological disease, and causality remains uncertain, further investigation is warranted to understand the nature and frequency of paresthesia as a possible AEFI with influenza vaccines.

Keywords: Adjuvanted vaccine; Adverse event; Influenza vaccine; Neurological; Safety.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Case-Control Studies
  • Child
  • Drug Combinations
  • Europe / epidemiology
  • Female
  • Humans
  • Influenza A Virus, H1N1 Subtype / immunology
  • Influenza Vaccines / administration & dosage*
  • Influenza Vaccines / adverse effects*
  • Influenza, Human / prevention & control
  • Influenza, Human / virology
  • Male
  • Middle Aged
  • Paresthesia / chemically induced*
  • Paresthesia / epidemiology*
  • Polysorbates / administration & dosage
  • Polysorbates / adverse effects
  • Quebec / epidemiology
  • Risk Factors
  • Squalene / administration & dosage
  • Squalene / adverse effects
  • Young Adult
  • alpha-Tocopherol / administration & dosage
  • alpha-Tocopherol / adverse effects

Substances

  • ASO3B adjuvant
  • Drug Combinations
  • Influenza Vaccines
  • Polysorbates
  • Squalene
  • alpha-Tocopherol