Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: Peripheral neuropathy of toes, feet, ankles and wrists/numbness in several toes/started having pain, burning, numbness in toes and feet/Burning, stabbing sensation in toes and feet; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NEUROPATHY PERIPHERAL (Peripheral neuropathy of toes, feet, ankles and wrists/numbness in several toes/started having pain, burning, numbness in toes and feet/Burning, stabbing sensation in toes and feet) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 030B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Confirmed with Rapid test on 11-Dec-2020) in December 2020. Concurrent medical conditions included Sulfonamide allergy (Reaction to sulfa). Concomitant products included CHLORTHALIDONE for Kidney stone, MULTIVITAMIN [VITAMINS NOS] and VITAMIN D NOS for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NEUROPATHY PERIPHERAL (Peripheral neuropathy of toes, feet, ankles and wrists/numbness in several toes/started having pain, burning, numbness in toes and feet/Burning, stabbing sensation in toes and feet) (seriousness criterion medically significant). The patient was treated with GABAPENTIN ongoing since an unknown date for Peripheral neuropathy, at a dose of 300 mg twice a day and CANNABIDIOL (CBD OIL) ongoing since an unknown date for Peripheral neuropathy, at a dose of UNK, prn. At the time of the report, NEUROPATHY PERIPHERAL (Peripheral neuropathy of toes, feet, ankles and wrists/numbness in several toes/started having pain, burning, numbness in toes and feet/Burning, stabbing sensation in toes and feet) had not resolved.            Additional concomitant medications included Khor-Con (15 mg) by oral route of administration started in 2007 for low potassium.  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.  However, more information is required for further assessment.  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.  However, more information is required for further assessment. FU1 received does not change company causality assessment.   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Reporter's information updated. Dose 2 batch number added. Medical history notes updated; treatment and concomitant medications were added or updated.; 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.  However, more information is required for further assessment. FU1 received does not change company causality assessment.