Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune neuropathy, Hypersensitivity, Inappropriate schedule of product administration
Clinical narrative: vaccine associated autoimmune neuropathy; The patient had an allergy; The patient received dose 1 on 30-Jan-2021 and dose 2 on 23-Feb-2022; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE NEUROPATHY (vaccine associated autoimmune neuropathy) in a 71-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Feb-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received dose 1 on 30-Jan-2021 and dose 2 on 23-Feb-2022). On an unknown date, the patient experienced AUTOIMMUNE NEUROPATHY (vaccine associated autoimmune neuropathy) (seriousness criterion medically significant) and HYPERSENSITIVITY (The patient had an allergy). At the time of the report, AUTOIMMUNE NEUROPATHY (vaccine associated autoimmune neuropathy) and HYPERSENSITIVITY (The patient had an allergy) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received dose 1 on 30-Jan-2021 and dose 2 on 23-Feb-2022) outcome was unknown.            Concomitant medication of the patient was not reported.  Lot number was reported as 213A21A.  The patient had a non-specific reaction after the second dose and had a strange feeling under her eyes and around her face. The patient lost her knee-jerk reflex on the left side and stated that the symptoms had never gone away.  No treatment information was provided by the reporter.  Company comment: This is a spontaneous case regarding a 71-year-old female patient, with no reported medical history, who completed a two-dose primary series of mRNA-1273 vaccine with an interval of 1 year 24 days between doses and experienced unexpected and medically significant event of autoimmune neuropathy after receiving the second dose. Onset date of the event was not provided, latency cannot be assessed. According to the report, patient had a non-specific reaction after the second dose and a strange feeling under her eyes and around her face, and also had an allergy. The patient was diagnosed with vaccine associated autoimmune neuropathy and lost her knee-jerk reflex on the left side. She stated that the symptoms have never gone away. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case regarding a 71-year-old female patient, with no reported medical history, who completed a two-dose primary series of mRNA-1273 vaccine with an interval of 1 year 24 days between doses and experienced unexpected and medically significant event of autoimmune neuropathy after receiving the second dose. Onset date of the event was not provided, latency cannot be assessed. According to the report, patient had a non-specific reaction after the second dose and a strange feeling under her eyes and around her face, and also had an allergy. The patient was diagnosed with vaccine associated autoimmune neuropathy and lost her knee-jerk reflex on the left side. She stated that the symptoms have never gone away. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.