Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: neuropathy-like symptoms that were more intense than before starting Aubagio; all of these changes were making her very upset emotionally; She wet the bed the other night; she had numbness in her arms and legs; she had tingling in her arms and legs; she had pain in her arms and legs; This spontaneous case was reported by a patient and describes the occurrence of NEUROPATHY PERIPHERAL (neuropathy-like symptoms that were more intense than before starting Aubagio) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TERIFLUNOMIDE (AUBAGIO) coated tablet for Multiple sclerosis.    Concurrent medical conditions included Multiple sclerosis since 2005, Gastrointestinal disorder (stomach and bowel problems.), Hypersensitivity and Neuropathy peripheral.   In May 2021, the patient started TERIFLUNOMIDE (AUBAGIO) (unknown route) 14 milligram once a day. On 21-Jun-2021, TERIFLUNOMIDE (AUBAGIO) (Oral) dosage was changed to 7 milligram once a day. On 21-Jul-2021, TERIFLUNOMIDE (AUBAGIO) (Oral) dosage was changed to 14 milligram once a day. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced EMOTIONAL DISTRESS (all of these changes were making her very upset emotionally), ENURESIS (She wet the bed the other night), HYPOAESTHESIA (she had numbness in her arms and legs), PARAESTHESIA (she had tingling in her arms and legs) and PAIN IN EXTREMITY (she had pain in her arms and legs). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (neuropathy-like symptoms that were more intense than before starting Aubagio) (seriousness criterion medically significant). At the time of the report, NEUROPATHY PERIPHERAL (neuropathy-like symptoms that were more intense than before starting Aubagio), EMOTIONAL DISTRESS (all of these changes were making her very upset emotionally), ENURESIS (She wet the bed the other night), HYPOAESTHESIA (she had numbness in her arms and legs), PARAESTHESIA (she had tingling in her arms and legs) and PAIN IN EXTREMITY (she had pain in her arms and legs) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: showed disease progression.         No concomitant medications were provided by the reporter.  The patient wanted to know if the symptoms were related to teriflunomide or her Multiple Sclerosis. Also, she wanted to know if the magnetic resonance imaging (MRI) showed disease progression do they need to do the Electromyography (EMG). The doctor told her some people had this after the third COVID dose. They wanted to do another EMG and she had a brain MRI scheduled for this Thursday as a follow up. Stated her practitioner told her the teriflunomide might have caused the "neuropathy" symptoms. She recently moved and changed doctors.  No treatment medications were provided by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked in.  Company Comment: This spontaneous case concerns a 63 year old female patient with relevant medical history of multiple sclerosis and peripheral neuropathy, who experienced the unexpected serious (medically significant) event of Neuropathy peripheral, unknown days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the previous two doses with the same vaccine (schedule unknown), the second dose being given about 4 months prior to the events reported. The primary series of vaccination did not have any adverse reactions. About 4 months after the second dose of mRNA-1273, she experienced increased spasticity and neuropathy symptoms in her hands, feet and legs with numbness and tingling. She reported increase in neuropathy-like symptoms that were more intense than before starting teriflunomide. She also wet the bed. Her physician suggested that some people had these symptoms after the third COVID 19 vaccination dose. Her practitioner also told her that teriflunomide might have caused the neuropathy'  symptoms.  Her investigations (EMG and MRI brain) were reported as scheduled and no result was available. The event was not resolved. Medical history of multiple sclerosis and peripheral neuropathy remain as confounding factors for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.  This case was linked to MOD-2021-624354 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 63 year old female patient with relevant medical history of multiple sclerosis and peripheral neuropathy, who experienced the unexpected serious (medically significant) event of Neuropathy peripheral, unknown days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the previous two doses with the same vaccine (schedule unknown), the second dose being given about 4 months prior to the events reported. The primary series of vaccination did not have any adverse reactions. About 4 months after the second dose of mRNA-1273, she experienced increased spasticity and neuropathy symptoms in her hands, feet and legs with numbness and tingling. She reported increase in neuropathy-like symptoms that were more intense than before starting teriflunomide. She also wet the bed. Her physician suggested that some people had these symptoms after the third COVID 19 vaccination dose. Her practitioner also told her that teriflunomide might have caused the neuropathy'  symptoms.  Her investigations (EMG and MRI brain) were reported as scheduled and no result was available. The event was not resolved. Medical history of multiple sclerosis and peripheral neuropathy remain as confounding factors for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.