Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Neuropathy peripheral, SARS-CoV-2 test
Clinical narrative: Had 1 covid episode after the vaccinations; severe peripheral neuropathy in her arms, legs, hands, feet and abdomen; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NEUROPATHY PERIPHERAL (severe peripheral neuropathy in her arms, legs, hands, feet and abdomen) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient had no history of allergies.  The patient's past medical history included COVID-19 (1 COVID episode before vaccinations). Concurrent medical conditions included Fabry's disease. Concomitant products included ETHINYLESTRADIOL, NORGESTIMATE (TRI-SPRINTEC) for Birth control.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced NEUROPATHY PERIPHERAL (severe peripheral neuropathy in her arms, legs, hands, feet and abdomen) (seriousness criterion medically significant). On an unknown date, the patient experienced COVID-19 (Had 1 covid episode after the vaccinations). The patient was treated with PREGABALIN (LYRICA) for Peripheral neuropathy, at an unspecified dose and frequency. At the time of the report, NEUROPATHY PERIPHERAL (severe peripheral neuropathy in her arms, legs, hands, feet and abdomen) had not resolved and COVID-19 (Had 1 covid episode after the vaccinations) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         It was reported that, when peripheral neuropathy initially occurred, it happened immediately within 24 hours and was thought it was due to the vaccine and the patient's doctors thought it could be due to genetic disease that triggered pain crisis from genetic disease called Fabry's disease. The patient was receiving treatment and stated that they thought something else was going on specific to the vaccine but not necessarily the disease and stated that, once the trigger was removed, pain was also removed. Patient had severe pain for 6 months now.  Company comment: This is a spontaneous case 21 years old female patient with Concurrent medical condition of  Fabry's disease, who experienced the unexpected serious event of neuropathy peripheral and unexpected non serious AESI event of Covid-19, which occurred unspecified days after third dose (booster) of mRNA-1273 vaccine. SARS-CoV-2 test is Positive. It is reported that when peripheral neuropathy initially occurred, it happened immediately within 24 hours and was thought it was due to the vaccine and the patient's doctors thought it could be due to genetic disease that triggered pain crisis from genetic disease called Fabry's disease. patient had severe pain for 6 months. Concurrent medical condition of Fabry's disease is confounding for the event neuropathy peripheral, Current ongoing pandemia is confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed as per Regulatory Authority reporting.; Sender's Comments: This is a spontaneous case 21 years old female patient with Concurrent medical condition of  Fabry's disease, who experienced the unexpected serious event of neuropathy peripheral and unexpected non serious AESI event of Covid-19, which occurred unspecified days after third dose (booster) of mRNA-1273 vaccine. SARS-CoV-2 test is Positive. It is reported that when peripheral neuropathy initially occurred, it happened immediately within 24 hours and was thought it was due to the vaccine and the patient's doctors thought it could be due to genetic disease that triggered pain crisis from genetic disease called Fabry's disease. patient had severe pain for 6 months. Concurrent medical condition of Fabry's disease is confounding for the event neuropathy peripheral, Current ongoing pandemia is confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed as per Regulatory Authority reporting.