Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: Increased Neuropathy,after each vaccine my Neuropathy got much Worse, burning and stinging in my feet got increasing; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Increased Neuropathy,after each vaccine my Neuropathy got much Worse, burning and stinging in my feet got increasing) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A, 031B21A and 068H21AB) for COVID-19 vaccination.     The patient's past medical history included Prostate cancer on 05-Jan-2013. Concurrent medical conditions included Type 2 diabetes mellitus (worse neuropathy) since 07-Jan-2016, Neuropathy since 15-Jun-2012 and Lyme disease (neuropathy) since 15-Jun-2012. Concomitant products included METFORMIN from January 2016 to an unknown date for Diabetes, GABAPENTIN from June 2012 to an unknown date for Lyme disease and Neuropathy.   On 03-Mar-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 dosage form. On 31-Mar-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 dosage form. On 05-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NEUROPATHY PERIPHERAL (Increased Neuropathy,after each vaccine my Neuropathy got much Worse, burning and stinging in my feet got increasing) (seriousness criterion medically significant). The patient was treated with INSULIN for Diabetes mellitus, at a dose of 1 dosage form. At the time of the report, NEUROPATHY PERIPHERAL (Increased Neuropathy,after each vaccine my Neuropathy got much Worse, burning and stinging in my feet got increasing) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Patient take insulin via catheter over several hours. The patient reports neuropathy prior to the first two initial vaccines, after each vaccine, his neuropathy gets worse. His doctor has given new insulin treatment which helped after the first two vaccines. Six months later, his neuropathy got worse after he got vaccine booster.   Company comment: This spontaneous case concerns a 68-year-old, male patient with relevant medical history of neuropathy due to Type 2 Diabetes Mellitus (T2DM) and Lyme disease, who experienced the unexpected, serious (medically significant) event of peripheral neuropathy. The patient experienced worsening neuropathy, described as 'numbness, stinging and burning' 2 days after receiving the first dose of mRNA 1273 COVID-19 vaccine. The patient was treated with insulin which helped with the neuropathy. The patient again had worsening of neuropathy after he received second dose (28 days after first dose) and third dose (6 months after). The re-challenge is positive, since patient experiences peripheral neuropathy after every vaccine. The medical history of neuropathy due to T2DM and Lyme disease, remain as confounders. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-442253, MOD-2022-491399 (Patient Link).; Sender's Comments: This spontaneous case concerns a 68-year-old, male patient with relevant medical history of neuropathy due to Type 2 Diabetes Mellitus (T2DM) and Lyme disease, who experienced the unexpected, serious (medically significant) event of peripheral neuropathy. The patient experienced worsening neuropathy, described as 'numbness, stinging and burning' 2 days after receiving the first dose of mRNA 1273 COVID-19 vaccine. The patient was treated with insulin which helped with the neuropathy. The patient again had worsening of neuropathy after he received second dose (28 days after first dose) and third dose (6 months after). The re-challenge is positive, since patient experiences peripheral neuropathy after every vaccine. The medical history of neuropathy due to T2DM and Lyme disease, remain as confounders. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.