Age: 87.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cardiac disorder, Neuropathy peripheral
Clinical narrative: neuropathy of my legs/leg pains/to my foot/from the hip down; stiff heart.; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (neuropathy of my legs/leg pains/to my foot/from the hip down) in an 87-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Question: Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Hx of Parkinson's disease.   The patient's past medical history included Rotator cuff injury (She broke her rotator cuff in the 80s). Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (lot number - 041L20A) on 12-Jan-2021, Moderna COVID-19 vaccine (lot number- 030M20A) on 09-Feb-2021, Moderna COVID-19 vaccine (lot number - 058A22-2A) on 08-Jun-2021, Moderna COVID-19 vaccine (lot number - 014F21A) on 27-Oct-2021 and Moderna COVID-19 vaccine; for Drug use for unknown indication: Influenza vaccine.. Past adverse reactions to the above products included No adverse reaction with Influenza vaccine., Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine and Moderna COVID-19 vaccine. Concurrent medical conditions included Parkinson's disease. Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    On 19-Dec-2022, the patient received sixth 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 NEUROPATHY PERIPHERAL (neuropathy of my legs/leg pains/to my foot/from the hip down) (seriousness criterion medically significant) and CARDIAC DISORDER (stiff heart.). At the time of the report, NEUROPATHY PERIPHERAL (neuropathy of my legs/leg pains/to my foot/from the hip down) and CARDIAC DISORDER (stiff heart.) 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.   Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient was diagnosed with neuropathy of my legs and a stiff heart which was started 2 months after receiving vaccine. Contact was currently in wheelchair. she was taking cardiac medicines Patient broke her rotator cuff in the 80s playing softball for the army. Patient received shots for pneumonia, shingles, and flu sometime along the way.  Company Comment: This is a Spontaneous case reported by a consumer, concerning an 87-year-old female patient, with relevant medical condition of Parkinson´s disease, who experienced the unexpected and serious (due to medically significant) event of Neuropathy peripheral, which occurred related to mRNA-1273.222 vaccine, administered as sixth dose within COVID-19 vaccination schedule. Patient reported she was diagnosed with neuropathy of her legs and a stiff heart. It started 2 months after receiving does of Moderna vaccine. She is currently in a wheelchair. She experiences leg pains from the hip down to her feet. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had not resolved. Underlying Parkinson´s disease could be a confounding factor for the event. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2023: Live Follow up-Significant Information Accepted-Narrative Updated, Event added