Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Headache, Neuropathy peripheral, Vaccination site pain
Clinical narrative: Numbness, stinging and burning; neuropathy increased, it got so much worse; loss of energy; light headache; only trouble was soreness in injection site; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Numbness, stinging and burning) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lyme disease (Patient has a history of neuropathy caused by Lyme disease.). Concurrent medical conditions included Type 2 diabetes mellitus (History of Neuropathy caused by Diabetes type 2). Concomitant products included INSULIN for Diabetes mellitus and Neuropathy, GABAPENTIN and METFORMIN for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Numbness, stinging and burning) (seriousness criterion medically significant), CONDITION AGGRAVATED (neuropathy increased, it got so much worse), ASTHENIA (loss of energy), HEADACHE (light headache) and VACCINATION SITE PAIN (only trouble was soreness in injection site). At the time of the report, NEUROPATHY PERIPHERAL (Numbness, stinging and burning) and CONDITION AGGRAVATED (neuropathy increased, it got so much worse) had not resolved and ASTHENIA (loss of energy), HEADACHE (light headache) and VACCINATION SITE PAIN (only trouble was soreness in injection site) outcome was unknown.            Patient uses slow-timing insulin infusion, once a week. A specialist uses a catether to inject a tiny amount of insulin with a little pump that treats diabetes and neuropathy. Patient had pain got so bad it is hard to sleep,   Company Comment: This spontaneous case concerns a 68-year-old, male patient with relevant medical history of Type 2 Diabetes Mellitus (T2DM) and Lyme disease, who experienced the unexpected, serious event of peripheral neuropathy, the unexpected, non-serious event of condition aggravated, and other associated unexpected and expected, non-serious events after administration of an unspecified dose of the Moderna mRNA-1273 vaccine. The patient experienced worsening neuropathy, described as 'numbness, stinging and burning'. He also experienced a light headache, loss of energy and soreness in the injection site. He is being given insulin via a slow-timing infusion pump. The events peripheral neuropathy and condition aggravated had not resolved at the time of the report. The outcomes of the other events were unknown at the time of the report. The medical history of T2DM and Lyme disease, which may cause the complication of neuropathy, remain as confounders. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 68-year-old, male patient with relevant medical history of Type 2 Diabetes Mellitus (T2DM) and Lyme disease, who experienced the unexpected, serious event of peripheral neuropathy, the unexpected, non-serious event of condition aggravated, and other associated unexpected and expected, non-serious events after administration of an unspecified dose of the Moderna mRNA-1273 vaccine. The patient experienced worsening neuropathy, described as 'numbness, stinging and burning'. He also experienced a light headache, loss of energy and soreness in the injection site. He is being given insulin via a slow-timing infusion pump. The events peripheral neuropathy and condition aggravated had not resolved at the time of the report. The outcomes of the other events were unknown at the time of the report. The medical history of T2DM and Lyme disease, which may cause the complication of neuropathy, remain as confounders. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.