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• W4200204842 abstract "Guillain-Barré syndrome after vaccination against COVID-19 has been reported worldwide.1Allen CM Ramsamy S Tarr AW et al.Guillain-Barré syndrome variant occurring after SARS-CoV-2 vaccination.Ann Neurol. 2021; 90: 315-318Crossref PubMed Scopus (32) Google Scholar, 2European Medicines AgencyCOVID-19 vaccine Janssen: Guillain-Barré syndrome listed as a very rare side effect.https://www.ema.europa.eu/en/news/covid-19-vaccine-janssen-guillain-barre-syndrome-listed-very-rare-side-effectDate: 2021Date accessed: August 9, 2021Google Scholar Albeit rare, Guillain-Barré syndrome after vaccination is of great public concern given that it could potentially result in life-threatening paralysis. We report the findings of two patients with Guillain-Barré syndrome after receiving the BNT162b2 vaccine (tozinameran, Pfizer–BioNTech) who were in complete remission from diffuse large B-cell lymphoma. An 80-year-old woman (patient 1) visited the Research Institute and Hospital of National Cancer Center (Goyang, South Korea) on June 30, 2021, and reported a 5-day history of gradual weakness in her right hand and both legs, preceded by a tingling sensation. She was in complete remission from diffuse large B-cell lymphoma; the last round of chemotherapy had been administered in March, 2015. Patient 1 received the second dose of the BNT162b2 vaccine on June 19, 2021. On neurological examination of patient 1, distal dominant weakness was noted with absent deep tendon reflexes. A nerve conduction study showed axonal type sensorimotor peripheral polyneuropathy. Detailed evaluation is shown in the appendix (pp 1–2). To rule out lymphoma relapse, 18F-fluorodeoxyglucose (18F-FDG) PET and CT was performed. Mild-to-moderate irregular increased 18F-FDG uptake along a neurovascular bundle was observed (figure, video). Since the initial clinical manifestation in patient 1 was not typical of Guillain-Barré syndrome, high-dose methylprednisolone therapy was initiated under the suspicion of inflammatory peripheral polyneuropathy or a lymphoma relapse. However, the symptoms of patient 1 progressed to quadriparesis. A follow-up nerve conduction study and an electromyographic study revealed subacute polyradiculoneuropathy. The acute motor and sensory axonal neuropathy form of Guillain-Barré syndrome was suspected, and intravenous immunoglobulin (IVIG; 2 g/kg) was administered. After IVIG infusion, the patient's pain and weakness improved slightly. She was referred to a rehabilitation facility after 22 days of hospital treatment. A 76-year-old woman (patient 2) presented with a tingling sensation in her upper and lower limbs, which had started from late June, 2021. She visited the emergency room of the Research Institute and Hospital of National Cancer Center on Aug 9, 2021, for repeated falls caused by bilateral lower limb weakness. The patient was in complete remission from diffuse large B-cell lymphoma; the last chemotherapy treatment was in February, 2021. Patient 2 received the second dose of the BNT162b2 vaccine on June 8, 2021. On neurological examination of patient 2, quadriparesis was observed, with the absence of deep tendon reflexes. Findings of a nerve conduction study indicated sensorimotor peripheral polyneuropathy compatible with Guillain-Barré syndrome. CSF analysis showed cytoalbuminologic dissociation. The patient was diagnosed with the acute inflammatory demyelinating polyneuropathy subtype of Guillain-Barré syndrome, and IVIG (2 g/kg) was administered. Proximal weakness of the upper limbs, and the tingling sensation, were relieved. Patient 2 was referred to a rehabilitation facility after 4 days of treatment in hospital. In South Korea, ChAdOx1 nCoV-19 (AZD1222, Oxford–AstraZeneca) and BNT162b2 vaccines had been predominantly used until August 2021, and thereafter a mixed combination of these vaccines was used (ChAdOx1 nCoV-19 for first dose and BNT162b2 for second dose). In November 2021, use of the ChAdOx1 nCoV-19 vaccine was ceased in South Korea. In July 2021, the European Medicines Agency and US Food and Drug Administration recommended increased awareness of Guillain-Barré syndrome after ChAdOx1 nCoV-19 and Ad26.COV2.S (Janssen) adenoviral vector vaccines.3European Medicines AgencyMeeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5–8 July 2021.https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-5-8-july-2021Date: 2021Date accessed: August 18, 2021Google Scholar, 4US Food and Drug AdministrationCoronavirus (COVID-19) update.https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-july-13-2021Date: 2021Date accessed: August 14, 2021Google Scholar As of Aug 15, 2021, according to the adverse event reports after COVID-19 immunisation in South Korea, acute paralysis events (including Guillain-Barré syndrome) occurred in 620 (0·0059%) of 10 409 265 recipients after at least one dose of the ChAdOx1 nCoV-19 vaccine and in 382 (0·0055%) of 6 908 787 recipients after at least one dose of the BNT162b2 vaccine; no significant difference was noted (p=0·25).5Korea Centers for Disease Control and PreventionTrends in the occurrence of adverse reactions in Korea.https://ncv.kdca.go.kr/board.es?mid=a11707010000&bid=0032Date: 2021Date accessed: August 15, 2021Google Scholar A caveat is that cases were not always refined by experienced neurologists. In this case series, two older women in remission from diffuse large B-cell lymphoma developed Guillain-Barré syndrome (acute motor and sensory axonal neuropathy and acute inflammatory demyelinating polyneuropathy subtypes) after receiving the BNT162b2 vaccine. Patient 1 fulfilled level 2 of the Brighton criteria for diagnostic certainty and patient 2 fulfilled level 1 of these criteria.6Fokke C van den Berg B Drenthen J Walgaard C van Doorn PA Jacobs BC Diagnosis of Guillain-Barré syndrome and validation of Brighton criteria.Brain. 2014; 137: 33-43Crossref PubMed Scopus (338) Google Scholar The calculated Naranjo adverse reaction scale score was 7, suggesting a probable association between the vaccination and Guillain-Barré syndrome.7Naranjo CA Busto U Sellers EM et al.A method for estimating the probability of adverse drug reactions.Clin Pharmacol Ther. 1981; 30: 239-245Crossref PubMed Scopus (7766) Google Scholar However, we cannot confirm the causal relation between Guillain-Barré syndrome and the BNT162b2 COVID-19 vaccine, since the two cases of Guillain-Barré syndrome reported could be coincidental, and our report presents the temporal relation (within 4 weeks) only. Notably, both patients had underlying B-cell lymphoma. Aberrant B-cell function, even in remission status, could trigger the development of Guillain-Barré syndrome after vaccination and would be a potential predisposing factor. Such an extensive vaccination drive that is underway, including all age groups (from young people to older adults), is an unprecedented event in the COVID-19 era. Therefore, we might now observe the development of Guillain-Barré syndrome among patients with diffuse large B-cell lymphoma. Collectively, we suggest that clinicians should be vigilant in suspecting a diagnosis of Guillain-Barré syndrome, particularly among patients with B-cell lymphoma. Additionally, to our knowledge, this is the first report of Guillain-Barré syndrome variants using 18F-FDG PET and CT. Patient 1 had visited hospital immediately after symptom onset, and 18F-FDG PET and CT showed mild-to-moderate irregular uptake of 18F-FDG along the peripheral nerves, possibly related to active inflammatory processes. Considering the previous history of these two patients, neurolymphomatosis could be a differential diagnosis, which we could not completely exclude.8Yanagiya R Ito S Yamada A et al.Immune-mediated neuropathy with anti-ganglioside antibodies in diffuse large B-cell lymphoma.Rinsho Ketsueki. 2019; 60 (in Japanese).: 761-766PubMed Google Scholar Nonetheless, neurolymphomatosis usually exhibits intense 18F-FDG uptake, up to the maximum standardised uptake values (5·0), with thickening of the involved nerve, and we did not see these findings in patient 1.9Strobel K Fischer K Hany TF Poryazova R Jung HH Sciatic nerve neurolymphomatosis: extent and therapy response assessment with PET/CT.Clin Nucl Med. 2007; 32: 646-648Crossref PubMed Scopus (35) Google Scholar Large vessel vasculitis would be another differential diagnosis. However, a large vessel, such as the aorta or femoral artery, was not involved, which led us to suspect polyneuropathy rather than vasculitis in patient 1.10Slart RHJA FDG-PET/CT(A) imaging in large vessel vasculitis and polymyalgia rheumatica: joint procedural recommendation of the EANM, SNMMI, and the PET Interest Group (PIG), and endorsed by the ASNC.Eur J Nucl Med Mol Imaging. 2018; 45: 1250-1269Crossref PubMed Scopus (152) Google Scholar JYC, SP, JJ, T-SK, YJC, and H-SE declare no competing interests. J-WH has received a grant from the National Research Foundation of Korea. S-HK lectured for Bayer Schering Pharma, Genzyme, and Merck Seron; consulted for Bayer Schering Pharma, Merck Serono, Biogen, Genzyme, and Union Chimique Belge; received honoraria from Bayer Schering Pharma, Merck Serono, Genzyme, and UCB; and received a grant from the National Research Foundation of Korea. HJK received a grant from the National Research Foundation of Korea and research support from Aprilbio and Eisai; and received consultancy and speaker fees from Alexion, Aprilbio, Biogen, Celltrion, Daewoong, Eisai, GC Pharma, HanAll BioPharma, MDimune, Merck Serono, Novartis, Roche, Sanofi Genzyme, Teva-Handok, Union Chimique Belge, and Viela Bio. The Institutional Review Board of the National Cancer Center (IRB number NCC-2021–0260) approved this study and waived the requirement for informed consent because of the use of de-identified data. JYC and SP contributed equally as first authors. Download .pdf (.93 MB) Help with pdf files Supplementary appendix https://www.thelancet.com/cms/asset/33540380-daf4-4017-9220-54bcc663b06d/mmc2.mp4Loading ... Download .mp4 (3.72 MB) Help with .mp4 files Supplementary VideoCoronal view of 18F-fluorodeoxyglucose PET in patient 1" @default.
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