Sex: U
Vaccine: COVID19
Symptoms: Feeling of despair, Neuropathy peripheral, Oral discomfort
Clinical narrative: Despair/Hopelessness; Burning mouth/ neuropathy triggered by Moderna 7 weeks ago continues; Burning mouth/ neuropathy triggered by Moderna 7 weeks ago continues; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Burning mouth/ neuropathy triggered by Moderna 7 weeks ago continues) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced NEUROPATHY PERIPHERAL (Burning mouth/ neuropathy triggered by Moderna 7 weeks ago continues) (seriousness criterion medically significant) and ORAL DISCOMFORT (Burning mouth/ neuropathy triggered by Moderna 7 weeks ago continues). On an unknown date, the patient experienced FEELING OF DESPAIR (Despair/Hopelessness). At the time of the report, NEUROPATHY PERIPHERAL (Burning mouth/ neuropathy triggered by Moderna 7 weeks ago continues) and ORAL DISCOMFORT (Burning mouth/ neuropathy triggered by Moderna 7 weeks ago continues) had not resolved and FEELING OF DESPAIR (Despair/Hopelessness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NEUROPATHY PERIPHERAL (Burning mouth/ neuropathy triggered by Moderna 7 weeks ago continues) and ORAL DISCOMFORT (Burning mouth/ neuropathy triggered by Moderna 7 weeks ago continues) to be related. No further causality assessment was provided for FEELING OF DESPAIR (Despair/Hopelessness).    Concomitant medications were not provided.  The patient had received the fourth COVID-19 vaccine, 1st Moderna.  Treatment medication were not provided.  Company Comment:  This spontaneous case concerns a patient of an unknown age and gender with no reported medical history, who experienced the unexpected serious (medically significant) event of Neuropathy peripheral on an unknown date after receiving mRNA-1273 vaccine given as 4th dose in the COVID-19 vaccination series.  Latency between vaccine and event cannot be established. Patient also presented with burning mouth which could either be peripheral and/or a central neuropathic disorder.  No information was provided on any other COVID-19 vaccination. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender with no reported medical history, who experienced the unexpected serious (medically significant) event of Neuropathy peripheral on an unknown date after receiving mRNA-1273 vaccine given as 4th dose in the COVID-19 vaccination series.  Latency between vaccine and event cannot be established. Patient also presented with burning mouth which could either be peripheral and/or a central neuropathic disorder.  No information was provided on any other COVID-19 vaccination. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.