Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre syndrome; This literature case was received on 21-Nov-2022 from a physician and concerned a patient of unreported age and gender.   The primary objective of this study was to investigate COVID-19 vaccine safety outcomes in patients with reported reactions to polyethylene glycol (PEG) and polysorbate containing medications and vaccines. Influenza, tetanus, pneumococcal and meningococcal vaccines were considered to potentially contain polysorbate.  The demographics, documented allergies, PEG and polysorbate reaction histories, allergy evaluations, and vaccine safety outcomes were received in 3 patient cohorts with possible PEG and polysorbate reactions. COVID-19 vaccine safety was reviewed in patients with PEG or polysorbate reactions documented in their electronic medical records at a tertiary academic medical center (cohort one), patients referred to Allergy and Immunology with reported PEG or polysorbate reactions (cohort two), in which the patient was included, and COVID-19 vaccine safety was also reviewed following reported symptoms (onset = 12 hours) to first-dose PEG-containing messenger RNA (mRNA) COVID-19 vaccine (cohort three).  The patient's medical history and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with influenza vaccine (brand not specified; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving influenza vaccine, the patient developed Guillain-Barre syndrome (GBS).   The outcome of the event was not reported.  The reporter did not provide causality assessment.  Results showed that of 252 patients in cohort one (n = 202) and cohort two (n = 50), 236 (94%) received mRNA COVID-19 vaccines (106 Pfizer, 130 Moderna); 235 received both doses. Only three patients from cohort two developed mild rash following vaccination. None of the 44 patients in cohort three with acute symptoms following first-dose mRNA COVID-19 vaccine (27 Pfizer, 17 Moderna) had previously reported PEG or polysorbate reactions. Of these 44 patients, 43 received the second dose and all three who developed symptoms following the second dose (one required epinephrine) had negative PEG skin testing.  In conclusion, patients with reported reactions to PEG and polysorbate safely received COVID-19 vaccines. PEG and polysorbate skin testing did not identify patients at risk for first dose or recurrent reactions to COVID-19 vaccines. Screening for PEG and polysorbate allergy may only increase vaccine hesitancy without identifying patients at risk for COVID-19 vaccine reactions.  The event of Guillain-Barre syndrome was considered to be medically significant by Physician within Seqirus' Pharmacovigilance and Risk Management Department.   This case was linked with the case 202208401, 202208590 and 202208593 (the same literature article).  Company comment: The primary objective of this study was to investigate COVID-19 vaccine safety outcomes in patients with reported reactions to polyethylene glycol (PEG) and polysorbate containing medications and vaccines. Influenza, tetanus, pneumococcal and meningococcal vaccines were considered to potentially contain polysorbate. A patient of unreported age and gender was vaccinated with influenza vaccine. An unknown amount of time after vaccination, the patient developed Guillain-Barre syndrome (GBS). The patient's medical history and concomitant medications were not reported. Information regarding relevant diagnostic findings was not reported. Causal role of the suspect vaccine is unassessable, due to lack of information provided and unclear chronology. Brighton Collaboration criteria for the event Guillain Barre syndrome could not be assessed with the currently available information.; Sender's Comments: The primary objective of this study was to investigate COVID-19 vaccine safety outcomes in patients with reported reactions to polyethylene glycol (PEG) and polysorbate containing medications and vaccines. Influenza, tetanus, pneumococcal and meningococcal vaccines were considered to potentially contain polysorbate. A patient of unreported age and gender was vaccinated with influenza vaccine. An unknown amount of time after vaccination, the patient developed Guillain-Barre syndrome (GBS). The patient's medical history and concomitant medications were not reported. Information regarding relevant diagnostic findings was not reported. Causal role of the suspect vaccine is unassessable, due to lack of information provided and unclear chronology. Brighton Collaboration criteria for the event Guillain Barre syndrome could not be assessed with the currently available information.