Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Cystitis, Diarrhoea, Disability, Eye inflammation, Hepatic enzyme increased
Clinical narrative: I'm disabled now/There is a whole dossier on my disability; he has vision problems, "dark" and some things he is not able to see anymore/I'm having problems with vision/getting vision problems; I'm very arthritic/stiffness, like arthritic type" and "like pain; "stiffness, like arthritic type" and "like pain/I started getting sore the first day; brain fog; "stiffness, like arthritic type" and "like pain; my memory is a little vague; beginning of the strep infection, I had a strep infection for over a year/I still have strep problems/I still have strep; I get infections like bladder infections and that type; my red blood cells, my white blood cells, are always off; my red blood cells, my white blood cells, are always off; there's a liver enzyme or CPN or something. The C is the enzyme that checks is always high; I bruise; hearing problems where, you know, things can be too loud" and "Very sensitive. Like my senses censor can be enhanced or decreased by a lot; I had diarrhea and that type of thing; rashes/I started getting a little bit of a rash/he still has rashes/Regarding rashes, Caller stated, "It's not like a constant rash but it's, I have them more often; I guess I'm having blood clot, I think possibly blood clot and swelling issues; a lot of inflammation in his eyes; I guess I'm having blood clot, I think possibly blood clot and swelling issues; I had Lyme disease/I still have the spirochete or the Lyme disease/long term Lyme disease; I'm having a lot of autoimmune problems; I'm having problems with infection; This spontaneous case was reported by a patient and describes the occurrence of BLINDNESS (he has vision problems, "dark" and some things he is not able to see anymore/I'm having problems with vision/getting vision problems), THROMBOSIS (I guess I'm having blood clot, I think possibly blood clot and swelling issues), DISABILITY (I'm disabled now/There is a whole dossier on my disability), LYME DISEASE (I had Lyme disease/I still have the spirochete or the Lyme disease/long term Lyme disease) and AUTOIMMUNE DISORDER (I'm having a lot of autoimmune problems) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 017B21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced THROMBOSIS (I guess I'm having blood clot, I think possibly blood clot and swelling issues) (seriousness criterion medically significant), LYME DISEASE (I had Lyme disease/I still have the spirochete or the Lyme disease/long term Lyme disease) (seriousness criterion medically significant), AUTOIMMUNE DISORDER (I'm having a lot of autoimmune problems) (seriousness criterion medically significant), INFECTION (I'm having problems with infection), SWELLING (I guess I'm having blood clot, I think possibly blood clot and swelling issues), EYE INFLAMMATION (a lot of inflammation in his eyes), MEMORY IMPAIRMENT (my memory is a little vague), STREPTOCOCCAL INFECTION (beginning of the strep infection, I had a strep infection for over a year/I still have strep problems/I still have strep), CYSTITIS (I get infections like bladder infections and that type), WHITE BLOOD CELL COUNT ABNORMAL (my red blood cells, my white blood cells, are always off), RED BLOOD CELL COUNT ABNORMAL (my red blood cells, my white blood cells, are always off), HEPATIC ENZYME INCREASED (there's a liver enzyme or CPN or something. The C is the enzyme that checks is always high), CONTUSION (I bruise), HYPOACUSIS (hearing problems where, you know, things can be too loud" and "Very sensitive. Like my senses censor can be enhanced or decreased by a lot), DIARRHOEA (I had diarrhea and that type of thing) and RASH (rashes/I started getting a little bit of a rash/he still has rashes/Regarding rashes, Caller stated, "It's not like a constant rash but it's, I have them more often). On 21-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BRAIN FOG (brain fog) and MUSCULOSKELETAL STIFFNESS ("stiffness, like arthritic type" and "like pain). On an unknown date, the patient experienced BLINDNESS (he has vision problems, "dark" and some things he is not able to see anymore/I'm having problems with vision/getting vision problems) (seriousness criterion medically significant), DISABILITY (I'm disabled now/There is a whole dossier on my disability) (seriousness criterion medically significant), ARTHRITIS (I'm very arthritic/stiffness, like arthritic type" and "like pain) and PAIN ("stiffness, like arthritic type" and "like pain/I started getting sore the first day). At the time of the report, BLINDNESS (he has vision problems, "dark" and some things he is not able to see anymore/I'm having problems with vision/getting vision problems), THROMBOSIS (I guess I'm having blood clot, I think possibly blood clot and swelling issues), DISABILITY (I'm disabled now/There is a whole dossier on my disability), LYME DISEASE (I had Lyme disease/I still have the spirochete or the Lyme disease/long term Lyme disease), AUTOIMMUNE DISORDER (I'm having a lot of autoimmune problems), INFECTION (I'm having problems with infection), ARTHRITIS (I'm very arthritic/stiffness, like arthritic type" and "like pain), SWELLING (I guess I'm having blood clot, I think possibly blood clot and swelling issues), EYE INFLAMMATION (a lot of inflammation in his eyes), BRAIN FOG (brain fog), MUSCULOSKELETAL STIFFNESS ("stiffness, like arthritic type" and "like pain), PAIN ("stiffness, like arthritic type" and "like pain/I started getting sore the first day), MEMORY IMPAIRMENT (my memory is a little vague), STREPTOCOCCAL INFECTION (beginning of the strep infection, I had a strep infection for over a year/I still have strep problems/I still have strep), CYSTITIS (I get infections like bladder infections and that type), WHITE BLOOD CELL COUNT ABNORMAL (my red blood cells, my white blood cells, are always off), RED BLOOD CELL COUNT ABNORMAL (my red blood cells, my white blood cells, are always off), HEPATIC ENZYME INCREASED (there's a liver enzyme or CPN or something. The C is the enzyme that checks is always high), CONTUSION (I bruise), HYPOACUSIS (hearing problems where, you know, things can be too loud" and "Very sensitive. Like my senses censor can be enhanced or decreased by a lot), DIARRHOEA (I had diarrhea and that type of thing) and RASH (rashes/I started getting a little bit of a rash/he still has rashes/Regarding rashes, Caller stated, "It's not like a constant rash but it's, I have them more often) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Reporter causality was not reported.  Patient had not received any other vaccines in the 4 weeks prior to COVID-19 vaccine Patient had to have a spinal fusion and started having problems a month after the second dose. Patient senses censor can be enhanced or decreased by a lot and he stated that this has been a "steady progression" after the second vaccine It was reported that vaccine was doing no good to the patient. Patient had IVs for like 8 weeks, had to do oral antibiotics for probably almost like two years. Patient think it is called long term COVID or not long term, long term Lyme disease. Treatment medications were not provided.  Company Comment: This spontaneous case concerns a 58-year-old male patient, with no medical history information reported, who experienced the unexpected serious (medically significant event) events of Thrombosis, Lyme disease, Autoimmune disorder that occurred after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine) and Blindness, Disability occurred after second dose. The patient also experienced non serious events of: Infection, Arthritis, Swelling, Eye inflammation, Brain fog, Musculoskeletal stiffness, Pain, Memory impairment, Streptococcal infection, Cystitis, White blood cell count abnormal, Red blood cell count abnormal, Hepatic enzyme increased, Contusion, Hypoacusis, Diarrhoea, Rash. Considering temporal relation and known safety profile  the events are assessed as related to mRNA-1273 apart of the Lyme disease which is different etiology. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2024: Live Significant follow-up received. Added onset date for the event thrombosis, infection, lyme disease, swelling, eye inflammation, rash, hearing impaired, bladder infection, memory impairment, hepatic enzyme increased, red blood cell count abnormal, white blood cell count abnormal, autoimmune disorder, bruise, streptococcal infection. Updated event verbatim for lyme disease. On 23-Sep-2024: Live follow up received contains non-significant information. Added reference numbers. On 23-Sep-2024: Live follow up received contains non-significant information. Added reference numbers.