Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Erythromelalgia, Incorrect route of product administration, Neuropathy peripheral, Postural orthostatic tachycardia syndrome
Clinical narrative: Erythromelagia, neuropathy, POtS; Erythromelagia, neuropathy, POtS; Erythromelagia, neuropathy, POtS; Inappropriate route of vaccination/ Incorrct route of administration; This case was initially received via another Manufacturer (Reference number: PVIUS2021001139) on 03-Aug-2021. The most recent information was received on 17-Aug-2021 and was forwarded to Moderna on 17-Aug-2021. The license partner had received the report from FDA VAERS (Reference number: 1528064).    This regulatory authority case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Erythromelagia, neuropathy, POTS), ERYTHROMELALGIA (Erythromelagia, neuropathy, POtS) and POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (Erythromelagia, neuropathy, POtS) in a 46-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.     Concurrent medical conditions included Food intolerance (No food allergies but can tolerate very little foods.).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Other) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Cutaneous) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination/ Incorrect route of administration). On 18-Feb-2021, the patient experienced NEUROPATHY PERIPHERAL (Erythromelagia, neuropathy, POtS) (seriousness criterion medically significant) and POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (Erythromelagia, neuropathy, POtS) (seriousness criterion medically significant). 18-Feb-2021, the patient experienced ERYTHROMELALGIA (Erythromelagia, neuropathy, POtS) (seriousness criterion medically significant). On 08-Feb-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination/ Incorrct route of administration) had resolved. At the time of the report, NEUROPATHY PERIPHERAL (Erythromelagia, neuropathy, POtS), ERYTHROMELALGIA (Erythromelagia, neuropathy, POtS) and POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (Erythromelagia, neuropathy, POtS) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Body temperature: fluctuations (abnormal) fluctuations in feet.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Cutaneous), the reporter did not provide any causality assessments.   No concomitant product information was provided by the reporter.  No treatment information was provided by the reporter.  It was reported that, 2 weeks after vaccine patient started having hot feet and it was progress to bulging veins, tingling in face, hands and feet.  On 18-Feb-2021, the patient experienced NEUROPATHY PERIPHERAL, ERYTHROMELALGIA  and POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME. On 08-Feb-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION had resolved. At the time of the report, NEUROPATHY PERIPHERAL, ERYTHROMELALGIA and POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME   had not resolved  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Follow-up document received and included new events neuropathy peripheral, erythromelalgia and start date of event added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.