Received Jan 21, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | — | — |
Developed myasthenia exacerbation; Developed myasthenia exacerbation; This is a literature report for the following literature source(s). INTRODUCTION: SARS-CoV-2 vaccination was recommended for patients with myasthenia gravis primarily based on expert consensus. Patients on immune modulatory therapy, and those with myasthenia gravis, were not included in the pivotal vaccine trials so safety and tolerability was not known for these patients. We systematically collected information about safety and tolerability of SARS-CoV-2 vaccination in our myasthenia gravis patient cohort. METHOD(S): As vaccine roll out started in December 2020, patients were asked to inform the study team about their vaccination status. Data was collected one of two ways using the same questionnaire, and data was recorded in the electronic medical records. Data was prospective when patients informed the clinic of scheduled date of vaccination; in such instances, study staff called patients within the first week of receiving each vaccination dose. In instances where patients did not contact the study team, data was collected retrospectively at the time of routine clinic visits. RESULT(S): To date, we have recorded information on 145 administered vaccine doses in 82 patients. This includes 81, 62 and 2 administered doses of the Pfizer- BioNTech, Moderna and Johnson & Johnson vaccines respectively. The majority of patients reported no or mild side effects, including mild injection site pain, malaise or generalized body aches, and did not experience worsening of their myasthenia. One patient who had been well controlled on prednisone monotherapy experienced progressive ptosis, diplopia and dysphagia two days after receiving his second dose of the Pfizer- BioNTech vaccine and was admitted to the hospital for impending myasthenic crisis. He was treated with plasmapheresis and had rapid initial recovery but had subsequent worsening requiring maintenance intravenous immunoglobulin (IVIg) therapy and higher prednisone dose. A second patient who was on prednisone and chronic IVIg developed myasthenia exacerbation 3 days after receiving his second dose of Pfizer- BioNTech vaccine and improved with increased frequency of IVIg and higher prednisone dose. All other patients experienced mild side effects similar to those reported in the vaccine clinical trials and had no significant worsening of their myasthenia gravis symptoms. CONCLUSION(S): For the majority patients in our cohort (98%), SARS-CoV-2 vaccination resulted in mild side effects very similar to those reported in the pivotal vaccine trials. Two patients however did have worsening of their myasthenia gravis, with one experiencing impending myasthenic crisis requiring hospitalization and emergent plasmapheresis. This is an ongoing effort, and the total number is expected to increase by the time of presentation.; Sender's Comments: As there is limited information in the case provided, the causal association between the events myasthenia gravis, and condition aggravated and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate. Linked Report(s) : US-PFIZER INC-PV202600006055 Same article/drug and different event/patient.;
Medical History/Concurrent Conditions: Myasthenia gravis