Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Fatigue, Feeling abnormal, Gait disturbance
Clinical narrative: Experienced brain fog ever since; Patient got a positive COVID test and had a mild case/headache/fatigue; Trouble walking; Intense headache/intense head pain; Intense fatigue; Intense/severe joint pain; Still have neurological issues 7 months later; lost her job of 20 years; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient got a positive COVID test and had a mild case/headache/fatigue) and NERVOUS SYSTEM DISORDER (Still have neurological issues 7 months later) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 06C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MONTELUKAST, VENLAFAXINE, TRAZODONE, ASA, FISH OIL, NIACIN and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced NERVOUS SYSTEM DISORDER (Still have neurological issues 7 months later) (seriousness criterion medically significant). On 20-Mar-2021, the patient experienced GAIT DISTURBANCE (Trouble walking), HEADACHE (Intense headache/intense head pain), FATIGUE (Intense fatigue) and ARTHRALGIA (Intense/severe joint pain). On 23-Mar-2021, the patient experienced COVID-19 (Patient got a positive COVID test and had a mild case/headache/fatigue) (seriousness criteria disability and medically significant). In 2021, the patient experienced LOSS OF EMPLOYMENT (lost her job of 20 years). On an unknown date, the patient experienced FEELING ABNORMAL (Experienced brain fog ever since). The patient was treated with GABAPENTIN for Headache, at an unspecified dose and frequency. At the time of the report, COVID-19 (Patient got a positive COVID test and had a mild case/headache/fatigue), NERVOUS SYSTEM DISORDER (Still have neurological issues 7 months later), LOSS OF EMPLOYMENT (lost her job of 20 years), FEELING ABNORMAL (Experienced brain fog ever since), GAIT DISTURBANCE (Trouble walking), HEADACHE (Intense headache/intense head pain), FATIGUE (Intense fatigue) and ARTHRALGIA (Intense/severe joint pain) outcome was unknown.            Patient mentioned that had been quite disabled, she had seen several doctors, and 2 neurologist.  Patient states that since then she had been quite disabled, she has seen several doctors, and 2 neurologist. She is still have neurological issues 7 months later. The symptoms began on 20March2021 of intense headache, intense head pain, intense/severe joint pain, trouble walking, lost her job of 20 years, and intense fatigue.  Company Comment: This case concerning a 54-year-old female patient, with no reported medical history who experienced the unexpected events of Covid-19 and nervous system disorder.  The events occurred on an unspecified date within the same month after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge not applicable as the events were reported exclusively after the last dose. The reporter did not provide the causality assessment of the events with product use. Covid-19 is assessed as not applicable based on biological etiology and known etiology. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event is assessed as serious (hospitalization) per regulatory reporting. Covid-19 is an adverse events of special interest   This case was linked to MOD-2021-375372 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Follow up contains concomitant and events Added( intense headache, intense head pain, intense fatigue).; Sender's Comments: This case concerning a 54-year-old female patient, with no reported medical history who experienced the unexpected events of Covid-19 and nervous system disorder.  The events occurred on an unspecified date within the same month after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge not applicable as the events were reported exclusively after the last dose. The reporter did not provide the causality assessment of the events with product use. Covid-19 is assessed as not applicable based on biological etiology and known etiology. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event is assessed as serious (hospitalization) per regulatory reporting. Covid-19 is an adverse events of special interest