Guillain-Barré Syndrome After High-Dose Influenza Vaccine Administration in the United States, 2018–2019 Season

Abstract

Background The Vaccine Safety Datalink (VSD) identified a statistical signal for an increased risk of Guillain-Barré syndrome (GBS) in days 1–42 after 2018–2019 high-dose influenza vaccine (IIV3-HD) administration. We evaluated the signal using Medicare. Methods We conducted early- and end-of-season claims-based self-controlled risk interval analyses among Medicare beneficiaries ages ≥65 years, using days 8–21 and 1–42 postvaccination as risk windows and days 43–84 as control window. The VSD conducted chart-confirmed analyses. Results Among 7 453 690 IIV3-HD vaccinations, we did not detect a statistically significant increased GBS risk for either the 8- to 21-day (odds ratio [OR], 1.85; 95% confidence interval [CI], 0.99–3.44) or 1- to 42-day (OR, 1.31; 95% CI, 0.78–2.18) risk windows. The findings from the end-of-season analyses were fully consistent with the early-season analyses for both the 8- to 21-day (OR, 1.64; 95% CI, 0.92–2.91) and 1- to 42-day (OR, 1.12; 95% CI, 0.70–1.79) risk windows. The VSD’s chart-confirmed analysis, involving 646 996 IIV3-HD vaccinations, with 1 case each in the risk and control windows, yielded a relative risk of 1.00 (95% CI, 0.06–15.99). Conclusions The Medicare analyses did not exclude an association between IIV3-HD and GBS, but it determined that, if such a risk existed, it was similar in magnitude to prior seasons. Chart-confirmed VSD results did not confirm an increased risk of GBS.

Case of Guillain-Barré syndrome following COVID-19 vaccine

“…There have been studies showing that there is a small risk of developing this condition after yearly influenza/influenza vaccines at about 1–2 cases per million influenza vaccine doses administered. 5 17–19 A case report by Waheed et al 8 described the first case of GBS after the initial dose of the Pfizer–BioNTech COVID-19 vaccine.…”

“… 3 The administration of outmoded antirabies vaccines and a New Jersey (swine) influenza vaccine given in the late 1976s were associated with a slight increase in the incidence of GBS 4 and at least one subsequent influenza vaccination programme has been associated with a marginal increase. 5 However, no definitive causal associations have been proven despite these individual reports being widely recited.…”

Guillain-Barré Syndrome After Ad26.COV2.S Vaccination

“…Interestingly, an association between various pathogens and specific GBS subtypes has been identified [ 7 ]. Whereas pathogen-borne antigens are an established antecedent for GBS, it remains unclear if a causative relationship exists with vaccinations [ 8 ]. An increased risk for GBS has been described after influenza A, measles/mumps/ rubella (MMR), human papillomavirus (HPV), tetanus, hepatitis, polio, adenovirus, and quadrivalent meningococcal vacci-nations [ 9 – 11 ].…”

Guillain-Barre Syndrome and COVID-19 Vaccine: A Report of Nine Patients

“…There are currently several types of vaccines against COVID-19, including inactivated virus, protein-based vaccines, viral vector vaccines, and mRNA vaccine, which some of them have been approved by the WHO emergency use listing, Food and Drugs Administration (FDA), and European Medicines Agency (EMA) ( Cavaleri, Enzmann, Straus, & Cooke, 2021 ; Coronavirus » Vaccination Information from Other Organisations, n.d.). In previous studies, the association of vaccines, including influenza, hepatitis B, polio, tetanus, meningococcus, rabies, and adenovirus vaccine with GBS has been reported ( Chen, Zhang, Chu, Xu, & Ma, 2020 ; McNeil et al, 2019 ; Perez-Vilar et al, 2021 ). Recently, several studies have reported the association between GBS and COVID-19 after receiving Pfizer, Oxford/AstraZeneca, and Johnson & Johnson COVID-19 vaccines (Allen et al, n.d.; Márquez Loza et al, 2021 ; Patel, Khurram, Lakhani, & Quirk, 2021 ; Waheed, Bayas, Hindi, Rizvi, & Espinosa, 2021 ).…”