Sex: F
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Nerve injury, Neurological examination, Small fibre neuropathy
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of AUTONOMIC NEUROPATHY (Diagnosed with Immune Mediated Autonomic Neuropathy/neurological injuries) and AUTONOMIC NERVOUS SYSTEM IMBALANCE (POTS Cardiovagal Dysfunction/Post Ganglionic Sudomotor dysfunction/ Small Fiber Neuropathy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced BURNS SECOND DEGREE (Didn't realize she burned her hand it until it blistered/she burned her hand). On 20-May-2021, the patient experienced FEELING ABNORMAL (Started feeling funny). On 24-May-2021, the patient experienced HYPOAESTHESIA (Numbness in her arms symmetrically/Numbness in her legs symmetrically) and LIMB INJURY (Cut her hands picking up broken glass). On 04-Oct-2021, the patient experienced AUTONOMIC NEUROPATHY (Diagnosed with Immune Mediated Autonomic Neuropathy/neurological injuries) (seriousness criterion medically significant) and AUTONOMIC NERVOUS SYSTEM IMBALANCE (POTS Cardiovagal Dysfunction/Post Ganglionic Sudomotor dysfunction/ Small Fiber Neuropathy) (seriousness criterion medically significant). At the time of the report, AUTONOMIC NEUROPATHY (Diagnosed with Immune Mediated Autonomic Neuropathy/neurological injuries), AUTONOMIC NERVOUS SYSTEM IMBALANCE (POTS Cardiovagal Dysfunction/Post Ganglionic Sudomotor dysfunction/ Small Fiber Neuropathy), FEELING ABNORMAL (Started feeling funny), HYPOAESTHESIA (Numbness in her arms symmetrically/Numbness in her legs symmetrically), LIMB INJURY (Cut her hands picking up broken glass) and BURNS SECOND DEGREE (Didn't realize she burned her hand it until it blistered/she burned her hand) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2021, Blood pressure measurement: abnormal (abnormal) 113/93. On 20-May-2021, Heart rate: high (High) 112. On 27-May-2021, Antinuclear antibody: abnormal (abnormal) abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications were not provided.  The treatment medication was reported as  Immunoglobulin Infusion, Intravenous IV, 4 consecutive days a month for three to seven months.  Company's comment: This case concerns a female patient of unknown age with no relevant medical history reported, who experienced the unexpected, serious (medically significant) events of autonomic nervous system imbalance and autonomic neuropathy. The events began approximately 15 days after the second dose of mRNA-1273. The rechallenge was not applicable since information about the fist dose has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-090632 (Patient Link).; Sender's Comments: This case concerns a female patient of unknown age with no relevant medical history reported, who experienced the unexpected, serious (medically significant) events of autonomic nervous system imbalance and autonomic neuropathy. The events began approximately 15 days after the second dose of mRNA-1273. The rechallenge was not applicable since information about the fist dose has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.