Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Autonomic neuropathy, Condition aggravated, Confusional state, Disturbance in attention, Dizziness
Clinical narrative: idiopathic peripheral neuropathy in feet; idiopathic peripheral neuropathy in feet has gotten worse; intermittent mild confusion; periods of loss of concentration; foggy; intermittent lightheadedness; This spontaneous case was reported by a physician and describes the occurrence of AUTONOMIC NEUROPATHY (idiopathic peripheral neuropathy in feet) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Moderna covid-19 vaccine (Dose 1, Lot no: 011L20A) on 29-Dec-2020 and Flu shot; for Drug use for unknown indication: Moderna covid-19 vaccine (Dose 2, lot no: 011L20A) on 27-Jan-2021 and Moderna covid-19 vaccine (Booster 1). Past adverse reactions to the above products included No adverse event with Flu shot and Moderna covid-19 vaccine; and No adverse reaction with Moderna covid-19 vaccine and Moderna covid-19 vaccine. Concurrent medical conditions included Idiopathic peripheral autonomic neuropathy (diagnosed years ago), Hypertension and Anxiety disorder. Concomitant products included SERTRALINE for Anxiety disorder, AMLODIPINE for Hypertension, GABAPENTIN for Peripheral neuropathy.    On 12-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced AUTONOMIC NEUROPATHY (idiopathic peripheral neuropathy in feet) (seriousness criterion medically significant), CONDITION AGGRAVATED (idiopathic peripheral neuropathy in feet has gotten worse), CONFUSIONAL STATE (intermittent mild confusion), DISTURBANCE IN ATTENTION (periods of loss of concentration), FEELING ABNORMAL (foggy) and DIZZINESS (intermittent lightheadedness). At the time of the report, AUTONOMIC NEUROPATHY (idiopathic peripheral neuropathy in feet), CONDITION AGGRAVATED (idiopathic peripheral neuropathy in feet has gotten worse), CONFUSIONAL STATE (intermittent mild confusion), DISTURBANCE IN ATTENTION (periods of loss of concentration), FEELING ABNORMAL (foggy) and DIZZINESS (intermittent lightheadedness) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was reported as patients preexisting condition of Idiopathic peripheral neuropathy in his feet has gotten worse. It started around timeframe when he received his Bivalent dose. Patient has had experienced a similar event in the past for many years. Treatment medication includes Gabapentin 100 mg 3 times per day. Patient did not have any medications, food and other products allergies. Patient has not ever had COVID test or diagnosis.  Company Comment:  This spontaneous case concerns a 72 year old male with a relevant medical history of idiopathic peripheral neuropathy in feet, who experienced the serious (medically significant) expected adverse event NEUROPATHY PERIPHERAL (idiopathic peripheral neuropathy in feet), which occurred unknown days after a dose of mRNA-1273 Bivalent .222 (Original/Omicron BA.4/5) vaccine administration given as the fourth dose. Condition aggravated was also reported. The outcome was reported as not resolved. Treatment medication includes Gabapentin 100 mg 3 times per day. Underlying history of idiopathic peripheral neuropathy in feet could be confounder for the event idiopathic peripheral neuropathy in feet has gotten worse. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 72 year old male with a relevant medical history of idiopathic peripheral neuropathy in feet, who experienced the serious (medically significant) expected adverse event NEUROPATHY PERIPHERAL (idiopathic peripheral neuropathy in feet), which occurred unknown days after a dose of mRNA-1273 Bivalent .222 (Original/Omicron BA.4/5) vaccine administration given as the fourth dose. Condition aggravated was also reported. The outcome was reported as not resolved. Treatment medication includes Gabapentin 100 mg 3 times per day. Underlying history of idiopathic peripheral neuropathy in feet could be confounder for the event idiopathic peripheral neuropathy in feet has gotten worse. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.