Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Loss of consciousness, Neurological symptom, Polycythaemia, Transient ischaemic attack
Clinical narrative: lost consciousness; fell off the examination table; hit head; polycythemia secondary; he had very low blood pressure; Moderna Vaccine had worsened his neurology from a 1-2 to an 8-9; He got an infection on his eye the next day; Can't walk like he used to be able to walk; he got shingles and the following week had a "mini-stroke" or TIA; he got shingles and the following week had a "mini-stroke" or TIA; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (lost consciousness), FALL (fell off the examination table), HEAD INJURY (hit head) and TRANSIENT ISCHAEMIC ATTACK (he got shingles and the following week had a "mini-stroke" or TIA) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A, 026L20A and G11F21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced GAIT INABILITY (Can't walk like he used to be able to walk). In 2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (he got shingles and the following week had a "mini-stroke" or TIA) (seriousness criterion medically significant) and HERPES ZOSTER (he got shingles and the following week had a "mini-stroke" or TIA). On 15-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EYE INFECTION (He got an infection on his eye the next day). In 2022, the patient experienced NEUROLOGICAL SYMPTOM (Moderna Vaccine had worsened his neurology from a 1-2 to an 8-9). In October 2022, the patient experienced LOSS OF CONSCIOUSNESS (lost consciousness) (seriousness criteria hospitalization prolonged and medically significant), FALL (fell off the examination table) (seriousness criterion hospitalization), HEAD INJURY (hit head) (seriousness criterion hospitalization) and HYPOTENSION (he had very low blood pressure). On an unknown date, the patient experienced POLYCYTHAEMIA (polycythemia secondary). The patient was hospitalized from sometime in October 2022 to sometime in October 2022 due to FALL, HEAD INJURY and LOSS OF CONSCIOUSNESS. At the time of the report, LOSS OF CONSCIOUSNESS (lost consciousness) and FALL (fell off the examination table) had resolved, HEAD INJURY (hit head) and HYPOTENSION (he had very low blood pressure) outcome was unknown and TRANSIENT ISCHAEMIC ATTACK (he got shingles and the following week had a "mini-stroke" or TIA), NEUROLOGICAL SYMPTOM (Moderna Vaccine had worsened his neurology from a 1-2 to an 8-9), HERPES ZOSTER (he got shingles and the following week had a "mini-stroke" or TIA), GAIT INABILITY (Can't walk like he used to be able to walk), EYE INFECTION (He got an infection on his eye the next day) and POLYCYTHAEMIA (polycythemia secondary) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NEUROLOGICAL SYMPTOM (Moderna Vaccine had worsened his neurology from a 1-2 to an 8-9) to be related. No further causality assessments were provided for LOSS OF CONSCIOUSNESS (lost consciousness), FALL (fell off the examination table), HEAD INJURY (hit head), TRANSIENT ISCHAEMIC ATTACK (he got shingles and the following week had a "mini-stroke" or TIA), HERPES ZOSTER (he got shingles and the following week had a "mini-stroke" or TIA), GAIT INABILITY (Can't walk like he used to be able to walk), EYE INFECTION (He got an infection on his eye the next day), HYPOTENSION (he had very low blood pressure) and POLYCYTHAEMIA (polycythemia secondary).    Concomitant medication was not reported. Patient had been a police officer for 48 years.  With his first shot he had no adverse reactions. At the beginning of 2021, after his second shot, he got shingles, and the following week had a "mini-stroke" or TIA. His hematologist thought he had a blood disease, polycythemia secondary. By Oct-2021. His hematologist told him to get the next shot. This shot, shot his immune system into the stratosphere. He got an infection on his eye the next day. In Feb-2022 he was backing out of garage and his feet got mixed up between the break and gas pedals. He drove to store. The next month he went to store and went to his bank. The ATM had glass around the ground. He was driving and almost hit another car, though he believes he was saved by the model of car he was driving. Thought he had a problem and saw a neurologist. His neurologist said that the Moderna Vaccine had worsened his neurology from a 1-2 to an 8-9. Believes that this was because of the Moderna COVID-19 vaccines. It's been nothing but hell. Can't walk like he used to be able to walk. Symptoms started Mar-2021 and have continued to today. He continues to not be able to drive. He tries to do 1 hour of physical activity a day. In Oct-2022 he had very low blood pressure. Went to an MD facility, fell off the examination table, hit head, and lost consciousness. He was put into a chair where he lost consciousness again, then was taken by ambulance to a hospital. He then spent 4 days in hospital in Oct-2022. He was seeing multiple primary care doctors, cardiologist, rheumatologist, hematologist, and endocrinologist. Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-757574 (E2B Linked Report).  Company Comment: This spontaneous case concerns a 64-year-old male patient, with medical history of high blood pressure, who experienced the unexpected and serious (medically significant) AESI of TRANSIENT ISCHAEMIC ATTACK and the unexpected and serious (hospitalization) events of LOSS OF CONSCIOUSNESS, FALL and HEAD INJURY, among other non-serious events. On the following week of the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) vaccine. His hematologist thought he had a blood disease, polycythemia secondary. One year after the third dose, during a medical consultation, he fell from the examination table and had a head injury with loss of consciousness, for which he was hospitalized for 4 days. Very limited information regarding the event TIA has been provided, further information has been requested. The company causality for the event FALL was assessed as not related due to lack of temporal association with mRNA-1273 vaccination and due to the nature of the event. The company causality for the events LOSS OF CONSCIOUSNESS and HEAD INJURY was assessed as not related since it was a consequence of the examination table falling. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2024: Live Significant follow up received. Patient demographic details were added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-757574:Different patient same product