Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Disorientation, Fall, Feeling abnormal, Gait disturbance
Clinical narrative: Complete disorientation; Everything was spinning/Even when he closed his eyes everything still felt off; Brain fog; inflammation or something (different attack of gout or arthritis) going through his body; Vision is burry; Can't get energy to do anything; When he walks for 10 minutes, he must sit for 30 minutes; fall; Ill for 2 to 3 days; he has been having fainting spells which he has never had before/1st fainting spell was within the 1st three days of the 2nd injection; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (he has been having fainting spells which he has never had before/1st fainting spell was within the 1st three days of the 2nd injection) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 046D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hepatitis C (Hepatitis C in 2015 (Medication Harvoni).) in 2015. Previously administered products included for Hepatitis C: HARVONI. Past adverse reactions to the above products included No adverse reaction with HARVONI. Concurrent medical conditions included Arthritis.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (Ill for 2 to 3 days). In May 2021, the patient experienced SYNCOPE (he has been having fainting spells which he has never had before/1st fainting spell was within the 1st three days of the 2nd injection) (seriousness criterion medically significant). On an unknown date, the patient experienced DISORIENTATION (Complete disorientation), VERTIGO (Everything was spinning/Even when he closed his eyes everything still felt off), FEELING ABNORMAL (Brain fog), INFLAMMATION (inflammation or something (different attack of gout or arthritis) going through his body), VISION BLURRED (Vision is burry), ASTHENIA (Can't get energy to do anything), GAIT DISTURBANCE (When he walks for 10 minutes, he must sit for 30 minutes) and FALL (fall). In May 2021, ILLNESS (Ill for 2 to 3 days) had resolved. At the time of the report, SYNCOPE (he has been having fainting spells which he has never had before/1st fainting spell was within the 1st three days of the 2nd injection), DISORIENTATION (Complete disorientation), VERTIGO (Everything was spinning/Even when he closed his eyes everything still felt off), FEELING ABNORMAL (Brain fog), INFLAMMATION (inflammation or something (different attack of gout or arthritis) going through his body), VISION BLURRED (Vision is burry) and ASTHENIA (Can't get energy to do anything) had not resolved and GAIT DISTURBANCE (When he walks for 10 minutes, he must sit for 30 minutes) and FALL (fall) outcome was unknown.            Concomitant medication of the patient was not reported. No treatment information was provided by the reporter.  Over the course of the next 6 months, he had been fainting spells which he has never had before. The 1st fainting spell was within the 1st three days of the 2nd injection. The other 3 times were random, he just got dizzy and fall. The last dizzy spell was very serious and even when  closed eyes everything still felt off. Since then, patient had been in brain fog, there was times where could not even put his name together and When something stressful comes up, he got completely disoriented. Had inflammation or something (different attack of gout or arthritis) going through his body and could not get energy to do anything.The symptoms got worsened.  And patient went to server specialist doctor.  Patient had no Allergies of medications, food, and other products. Patient never had COVID + test or diagnosis.  No other vaccines given within 1 month prior to Moderna COVID-19 and the patient has not experienced similar event in the past.  Company comment: This spontaneous case concerns a 65-year-old male patient with relevant medical history of Hepatitis-c, who experienced the unexpected serious (medically significant) event of Syncope (reported as multiple episodes of fainting spells) unknown days after second dose of mRNA-1273 vaccine. Medical history of Hepatitis-c could be confounding for the event. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-498565 (Patient Link).; Sender's Comments: This spontaneous case concerns a 65-year-old male patient with relevant medical history of Hepatitis-c, who experienced the unexpected serious (medically significant) event of Syncope (reported as multiple episodes of fainting spells) unknown days after second dose of mRNA-1273 vaccine. Medical history of Hepatitis-c could be confounding for the event. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.