Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: Neuropathy got much worse after booster; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy got much worse after booster) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A, 031A21A and 031B21A) for COVID-19 vaccination.     The patient's past medical history included Lyme disease (Neuropathy was provided as treatment on worsening.) on 15-Jun-2012. Concurrent medical conditions included Type II diabetes mellitus (Neuropathy was provided as treatment on worsening.) since 07-Jan-2016, Neuropathy since 15-Jun-2012 and Prostate cancer since 01-May-2013. Concomitant products included METFORMIN from January 2016 to an unknown date for Diabetes, GABAPENTIN from June 2012 to an unknown date for Lyme disease.   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 milliliter. 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 milliliter. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy got much worse after booster) (seriousness criterion medically significant). The patient was treated with INSULIN at an unspecified dose and frequency. At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy got much worse after booster) had not resolved.            On 11-Jan patient had experienced much more neuropathy with outcome ongoing/ not recovered. Patient mentioned he had some neuropathy prior to the first two initial vaccines. After each vaccine, his neuropathy got much worse. His doctor started insulin treatment, where tiny amounts of insulin was given via catheter over several hours.  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' on the same day after receiving the first and second dose of mRNA 1273 COVID-19 vaccine and was treated with insulin infusion. The patient again had worsening of neuropathy on unspecified date after he received third dose of mRNA 1273 vaccine. The re-challenge is positive since patient had worsening of peripheral neuropathy after each dose of the vaccine. The medical history of neuropathy due to T2DM and Lyme disease and the concurrent disease T2DM, remain as confounders. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-491381, MOD-2022-442253 (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' on the same day after receiving the first and second dose of mRNA 1273 COVID-19 vaccine and was treated with insulin infusion. The patient again had worsening of neuropathy on unspecified date after he received third dose of mRNA 1273 vaccine. The re-challenge is positive since patient had worsening of peripheral neuropathy after each dose of the vaccine. The medical history of neuropathy due to T2DM and Lyme disease and the concurrent disease T2DM, remain as confounders. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.