Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Psychotic disorder, Seizure, Tinnitus, Vaccination site infection, Vaccination site reaction
Clinical narrative: convulsions/had Seizures; can't listen/hypertensive hearing; Brain was swollen; have the smoking gun ordinary infectious disease; have the infection of his arm from the vaccination; Gap in his tooth; He got brain damage; Shot 1 broke a cyst at the injection site; tinnitus; He got COVID-19; Parkinson's/had trouble with Parkinson's/lumber spine is messed up/brain was shaking, internal organs were shaking/left eyeball dances/He was developing all the symptoms of Parkinson's/ Couldn't swallow, couldn't eat/He lost his way of life; ice pick headache; psychotic episode/psychotic mania and the crockery/he has a broken brain, psychotic events, and delusions which got worse with additional stress of losing his home; This spontaneous case was reported by a patient and describes the occurrence of PARKINSON'S DISEASE (Parkinson's/had trouble with Parkinson's/lumber spine is messed up/brain was shaking, internal organs were shaking/left eyeball dances/He was developing all the symptoms of Parkinson's/ Couldn't swallow, couldn't eat/He lost his way of life), SEIZURE (convulsions/had Seizures), DEAFNESS (can't listen/hypertensive hearing) and BRAIN OEDEMA (Brain was swollen) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products LEVODOPA for an unknown indication and CARBIDOPA for an unknown indication.    The patient's past medical history included Measles (at age 68 year old, He also had measles when he was 3 or 4) and Colonoscopy. Previously administered products included for Product used for unknown indication: MMR VACCIN (had a reaction to the MMR vaccine as a child). Past adverse reactions to the above products included Vaccination adverse reaction with MMR VACCIN. Concurrent medical conditions included Parkinson's disease, COPD and Cane user (walk with a cane).   On 06-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started LEVODOPA (unknown route) at an unspecified dose and CARBIDOPA (unknown route) at an unspecified dose. On 06-Sep-2021, the patient experienced PARKINSON'S DISEASE (Parkinson's/had trouble with Parkinson's/lumber spine is messed up/brain was shaking, internal organs were shaking/left eyeball dances/He was developing all the symptoms of Parkinson's/ Couldn't swallow, couldn't eat/He lost his way of life) (seriousness criterion medically significant), PSYCHOTIC DISORDER (psychotic episode/psychotic mania and the crockery/he has a broken brain, psychotic events, and delusions which got worse with additional stress of losing his home), COVID-19 (He got COVID-19) and HEADACHE (ice pick headache). On an unknown date, the patient experienced SEIZURE (convulsions/had Seizures) (seriousness criterion medically significant), DEAFNESS (can't listen/hypertensive hearing) (seriousness criterion medically significant), BRAIN OEDEMA (Brain was swollen) (seriousness criterion medically significant), TINNITUS (tinnitus), INFECTION (have the smoking gun ordinary infectious disease), VACCINATION SITE INFECTION (have the infection of his arm from the vaccination), DIASTEMA (Gap in his tooth), CEREBRAL DISORDER (He got brain damage) and VACCINATION SITE REACTION (Shot 1 broke a cyst at the injection site). At the time of the report, PARKINSON'S DISEASE (Parkinson's/had trouble with Parkinson's/lumber spine is messed up/brain was shaking, internal organs were shaking/left eyeball dances/He was developing all the symptoms of Parkinson's/ Couldn't swallow, couldn't eat/He lost his way of life), SEIZURE (convulsions/had Seizures), PSYCHOTIC DISORDER (psychotic episode/psychotic mania and the crockery/he has a broken brain, psychotic events, and delusions which got worse with additional stress of losing his home), TINNITUS (tinnitus), COVID-19 (He got COVID-19) and HEADACHE (ice pick headache) had not resolved and DEAFNESS (can't listen/hypertensive hearing), BRAIN OEDEMA (Brain was swollen), INFECTION (have the smoking gun ordinary infectious disease), VACCINATION SITE INFECTION (have the infection of his arm from the vaccination), DIASTEMA (Gap in his tooth), CEREBRAL DISORDER (He got brain damage) and VACCINATION SITE REACTION (Shot 1 broke a cyst at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, DNA test for fragile X: Recessive gene. On an unknown date, Laboratory test: Received testing showing a COMG gene, RS 4680, and Intermediate dopamine levels/have the recessing G sequence. On an unknown date, Weight: Lost 11 lbs of water in 9 days after seeing deep tissue person.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Patient have the recessive gene. One of them that would have led him to Parkinson's. Vaccine went straight to his brain. He went through a psychotic episode. He couldn't read, he couldn't listen. Patient have the smoking gun ordinary infectious disease. He has the infection of his arm from the vaccination. Second time in his life he lost everything because of this.After he got the vaccine and had trouble with Parkinson's, his lumber spine was messed up, he had convulsions. His brain was shaking, his internal organs were shaking. His brain was swollen. He became insane. He haven't slept since. His left eyeball dances. Patient was spastic, had Seizures, tremors, tinnitus, hypertensive hearing. Patient walk with a cane and had the recessing G sequence. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Shot 1 broke a cyst at the injection site and shot 2 stopped in his arm. Shot 1 went straight into his bloodstream. He claims he has a broken brain, psychotic events, and delusions which got worse with additional stress of losing his home. He went to get a colonoscopy. He got COVID-19 when it was bad in the Northeast. He never felt like he got well. He was developing all the symptoms of Parkinson's. Tremors were not constant. Tremors multiplied by 1000, couldn't speak, having fits, mania. Couldn't swallow, couldn't eat. Sensations of a different kind. Ice pick headache down in his brainstem. Felt like his headache was like fireworks. Touch side of his head and his eye closes. Lost control of the side of his body from the vaccine until Christmas. He was in the gym regularly to build this up. Stage 2 Parkinson's and Doctors just wanted to put him on psych meds. Believes he had repetitive non-impact concussion system. He doesn't get sick and hasn't been sick for 25 years. He has a tuning fork that has kept him alive his whole life. He got brain damage with this.  No treatment medication reported  Company Comment: This spontaneous case concerns a 71-year-old male, with relevant medical history of Parkinson's disease and Chronic obstructive pulmonary disease, who experienced the unexpected serious (Medically significant) events of Parkinson's disease(Parkinson's disease aggravated), Seizure(AESI), Deafness and Brain oedema that occurred in the context of first dose of mRNA-1273 vaccine in COVID-19 vaccination series. The event Parkinson's disease occurred on the same day of receiving the first dose of Moderna vaccine and all other events occurred on an unknown date. Patient has received another dose of Moderna vaccine about 28 days after the first dose. Patient reported that, Shot 1 broke a cyst at the injection site and shot 2 stopped in his arm. Shot 1 went straight into his bloodstream. He claims he has a broken brain, psychotic events, and delusions which got worse with additional stress. He went to get a colonoscopy. He got COVID-19. He never felt like he got well. He was developing all the symptoms of Parkinson's. Tremors were not constant, couldn't speak, having fits, mania, Couldn't swallow, couldn't eat, Sensations of a different kind and headache. Lost control of the side of his body from the vaccine. Received testing showing a COMG gene, RS 4680, and Intermediate dopamine levels. Believes he had "repetitive non-impact concussion system". No further information was available for medical review. The outcome of the events Parkinson's disease, Seizure was not recovered, Deafness and Brain oedema was unknown. Patients' medical history of Parkinson's disease remains as a confounder for Parkinson's disease aggravated. The benefit-risk relationship of mRNA-1273 Vaccine in not affected by this report.  Most recent FOLLOW-UP information incorporated above includes: On 13-Mar-2023: Live significant follow-up received included product information, new events, narrative updated On 13-Mar-2023: Live significant follow-up included Reporter added, DOB updated, gender, Relevant Medical History, events, Dosage and Relevant Information, suspect drug added and Narrative updated; Sender's Comments: This spontaneous case concerns a 71-year-old male, with relevant medical history of Parkinson's disease and Chronic obstructive pulmonary disease, who experienced the unexpected serious (Medically significant) events of Parkinson's disease(Parkinson's disease aggravated), Seizure(AESI), Deafness and Brain oedema that occurred in the context of first dose of mRNA-1273 vaccine in COVID-19 vaccination series. The event Parkinson's disease occurred on the same day of receiving the first dose of Moderna vaccine and all other events occurred on an unknown date. Patient has received another dose of Moderna vaccine about 28 days after the first dose. Patient reported that, Shot 1 broke a cyst at the injection site and shot 2 stopped in his arm. Shot 1 went straight into his bloodstream. He claims he has a broken brain, psychotic events, and delusions which got worse with additional stress. He went to get a colonoscopy. He got COVID-19. He never felt like he got well. He was developing all the symptoms of Parkinson's. Tremors were not constant, couldn't speak, having fits, mania, Couldn't swallow, couldn't eat, Sensations of a different kind and headache. Lost control of the side of his body from the vaccine. Received testing showing a COMG gene, RS 4680, and Intermediate dopamine levels. Believes he had "repetitive non-impact concussion system". No further information was available for medical review. The outcome of the events Parkinson's disease, Seizure was not recovered, Deafness and Brain oedema was unknown. Patients' medical history of Parkinson's disease remains as a confounder for Parkinson's disease aggravated. The benefit-risk relationship of mRNA-1273 Vaccine in not affected by this report.