Received May 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | 031A21A | IM |
cidp; tinnitus; vertigo; pots; lost my thyroid; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a patient and describes the occurrence of CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (cidp) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 045A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 19-Apr-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 20-Apr-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 20-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (cidp) (seriousness criterion medically significant), TINNITUS (tinnitus), VERTIGO (vertigo), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (pots) and THYROID DISORDER (lost my thyroid). At the time of the report, CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (cidp), TINNITUS (tinnitus), VERTIGO (vertigo), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (pots) and THYROID DISORDER (lost my thyroid) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown. No concomitant medication was reported. Patient administered dose on 20-Apr-2021 of batches (031A21A or 045A21A). It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.