Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Dyspnoea, Neuropathy peripheral, Therapeutic response unexpected
Clinical narrative: Felt bilateral numbness from above the knee to the toes/He was diagnosed with Idiopathic Peripheral Neuropathy in both legs.; The doctor informed him that he has Supraventricular Bigeminy; Vertigo; Short of breath; He did not experience high blood pressure after 2nd vaccine; Dizzy; This spontaneous case was reported by a pharmacist and describes the occurrence of NEUROPATHY PERIPHERAL (Felt bilateral numbness from above the knee to the toes/He was diagnosed with Idiopathic Peripheral Neuropathy in both legs.) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 067F21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shoulder operation on 26-Oct-2021. Previously administered products included for Product used for unknown indication: Moderna COVID-19 Vaccine (Lot# 006M20A & Exp. Date: unknown.) on 13-Feb-2021. Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 Vaccine. Concurrent medical conditions included Blood pressure high.   On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, received third 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 (Felt bilateral numbness from above the knee to the toes/He was diagnosed with Idiopathic Peripheral Neuropathy in both legs.) (seriousness criterion medically significant), VENTRICULAR EXTRASYSTOLES (The doctor informed him that he has Supraventricular Bigeminy), VERTIGO (Vertigo), DYSPNOEA (Short of breath), THERAPEUTIC RESPONSE UNEXPECTED (He did not experience high blood pressure after 2nd vaccine) and DIZZINESS (Dizzy). At the time of the report, NEUROPATHY PERIPHERAL (Felt bilateral numbness from above the knee to the toes/He was diagnosed with Idiopathic Peripheral Neuropathy in both legs.), VENTRICULAR EXTRASYSTOLES (The doctor informed him that he has Supraventricular Bigeminy), VERTIGO (Vertigo), DYSPNOEA (Short of breath), THERAPEUTIC RESPONSE UNEXPECTED (He did not experience high blood pressure after 2nd vaccine) and DIZZINESS (Dizzy) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 118/74 mmHg.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient stated that almost right away after the 2nd vaccine (does not remember exact date), he felt bilateral numbness from above the knee to the toes. On 23JAN2023, that condition was continued. He was diagnosed with Idiopathic Peripheral Neuropathy in both legs. Several months after the 2nd shot, at the end of June2021 or beginning of July2021, he felt Dizzy, had Vertigo, and he was short of breath. He had shoulder surgery in 26OCT2021 and they did pre-surgery work up in SEP2021. The doctor informed him that he had Supraventricular Bigeminy. He stated that his blood pressure has always been 118/74mmHg and he was totally healthy prior to vaccination. He did not experience high blood pressure after 2nd vaccine. He did not have COVID Disease until 2022, which was the new variant. The doctor at the hospital told him to just watch the Supraventricular Bigeminy, avoid strenuous activity and Coffee.  Company Comment :This spontaneous case concerns an elderly male patient aged 71 years with relevant medical history of Hypertension reported, who experienced the unexpected serious (medically significant) event of Neuropathy peripheral along with non-serious AESI event of Ventricular extrasystoles after second dose of mRNA-1273 vaccination. Latency cannot be assessed since onset date of events was not disclosed. Patient felt bilateral numbness from above knee to the toes after the second dose. Consulted a neurologist, as symptoms persisted and was diagnosed with Idiopathic Peripheral Neuropathy in both legs. Two to three months after 2nd dose, he felt Dizziness, Vertigo, and was short of breath. No further details available. During a pre-surgery work up (for shoulder surgery about 6-7 months after vaccination) he was found to have Supraventricular Bigeminy. He was advised to avoid strenuous activity and regular follow ups. Patient did not experience high blood pressure after 2nd vaccine, Therapeutic response unexpected was noted. Outcome of the events was not resolved. Elderly age of the patient remains as risk factor for the events, relevant medical history could be confounder to the event Ventricular extrasystoles. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an elderly male patient aged 71 years with relevant medical history of Hypertension reported, who experienced the unexpected serious (medically significant) event of Neuropathy peripheral along with non-serious AESI event of Ventricular extrasystoles after second dose of mRNA-1273 vaccination. Latency cannot be assessed since onset date of events was not disclosed. Patient felt bilateral numbness from above knee to the toes after the second dose. Consulted a neurologist, as symptoms persisted and was diagnosed with Idiopathic Peripheral Neuropathy in both legs. Two to three months after 2nd dose, he felt Dizziness, Vertigo, and was short of breath. No further details available. During a pre-surgery work up (for shoulder surgery about 6-7 months after vaccination) he was found to have Supraventricular Bigeminy. He was advised to avoid strenuous activity and regular follow ups. Patient did not experience high blood pressure after 2nd vaccine, Therapeutic response unexpected was noted. Outcome of the events was not resolved. Elderly age of the patient remains as risk factor for the events, relevant medical history could be confounder to the event Ventricular extrasystoles. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.