Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Dysstasia, Impaired work ability, Loss of personal independence in daily activities, Lumbar puncture
Clinical narrative: now hardly able to work; having difficulty getting around/ She sold her car as she cannot drive anymore; She is a fall risk, has a hard time staying upright; Chronic inflammatory demyelinating polyneuropathy/neuropathy on her toes/neuropathy on her waist/neuropathy on her hands; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (Chronic inflammatory demyelinating polyneuropathy/neuropathy on her toes/neuropathy on her waist/neuropathy on her hands) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Mild) in July 2020, Asthma (asthma attacks a couple of years back), Blood pressure abnormal and Thyroidectomy. Previously administered products included for Flu: Flu vaccine in October 2021; for Shingles: Shingles vaccine (2nd dose) in October 2021 and Shingles vaccine (1st dose); for Thyroidectomy: Synthroid (Synthroid 125mg once a day). Past adverse reactions to the above products included No adverse event with Flu vaccine, Shingles vaccine, Shingles vaccine and Synthroid. Concurrent medical conditions included Drug allergy (Codeine), Bundle branch block left and Bundle branch block right. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (Chronic inflammatory demyelinating polyneuropathy/neuropathy on her toes/neuropathy on her waist/neuropathy on her hands) (seriousness criterion medically significant). On an unknown date, the patient experienced IMPAIRED WORK ABILITY (now hardly able to work), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (having difficulty getting around/ She sold her car as she cannot drive anymore) and DYSSTASIA (She is a fall risk, has a hard time staying upright). At the time of the report, CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (Chronic inflammatory demyelinating polyneuropathy/neuropathy on her toes/neuropathy on her waist/neuropathy on her hands), IMPAIRED WORK ABILITY (now hardly able to work), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (having difficulty getting around/ She sold her car as she cannot drive anymore) and DYSSTASIA (She is a fall risk, has a hard time staying upright) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2020, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Lumbar puncture: high protein level (in the 90s). (abnormal) high protein level (in the 90s). and high protein level (in the 90s). (abnormal) high protein level (in the 90s)..         Concomitant medications reported included unspecified Blood pressure medication.  She underwent 6 MRIs of which the results are unavailable and 2 spinal taps and the result of the spinal tap revealed high protein level (in the 90s). She cannot see any other possible cause of this except her getting the Moderna COVID-19 vaccine. She sold her car as she cannot drive anymore and she was staying with her daughter.  No treatment medications were reported.  Company Comment:  This is a spontaneous case concerning  a  77-year-old, female patient with no relevant medical history, who experienced the unexpected serious AESI (medically significant) event of Chronic inflammatory demyelinating polyradiculoneuropathy and unexpected non-serious events of Impaired work ability, Loss of personal independence in daily activities, Dysstasia. The event Chronic inflammatory demyelinating polyradiculoneuropathy occurred on an unknown date in May 2022, after the second dose of mRNA-1273 COVID 19 Vaccine which was administered on February 16, 2021. On an unknown date the unexpected non-serious events of Impaired work ability, Loss of personal independence in daily activities, Dysstasia occurred. Patients underwent lumbar puncture, results showed abnormal results. Patient also underwent 6 MRIs results are unavailable. No treatment medications were reported. The events were reported as not resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: Company Comment:  This is a spontaneous case concerning  a  77-year-old, female patient with no relevant medical history, who experienced the unexpected serious AESI (medically significant) event of Chronic inflammatory demyelinating polyradiculoneuropathy and unexpected non-serious events of Impaired work ability, Loss of personal independence in daily activities, Dysstasia. The event Chronic inflammatory demyelinating polyradiculoneuropathy occurred on an unknown date in May 2022, after the second dose of mRNA-1273 COVID 19 Vaccine which was administered on February 16, 2021. On an unknown date the unexpected non-serious events of Impaired work ability, Loss of personal independence in daily activities, Dysstasia occurred. Patients underwent lumbar puncture, results showed abnormal results. Patient also underwent 6 MRIs results are unavailable. No treatment medications were reported. The events were reported as not resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.