Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Pain in extremity, Paralysis, Psychotic disorder, Pyrexia
Clinical narrative: paralysis; psychosis; speaking in third tongue/neuropathy; anxiety; rash; fever; pain in the arm; seizure; sweats all the time; chest pain/chronic pain; he is still thirsty and takes a lot of water; can't sleep; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (pain in the arm), RASH (rash), PYREXIA (fever), SEIZURE (seizure), PARALYSIS (paralysis), PSYCHOTIC DISORDER (psychosis), NEUROPATHY PERIPHERAL (speaking in third tongue/neuropathy) and ANXIETY (anxiety) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient's past medical history included Meningitis borrelia, Epstein-Barr virus infection and Lyme disease. Concurrent medical conditions included Immunodeficiency common variable.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm) (seriousness criterion hospitalization) and PYREXIA (fever) (seriousness criterion hospitalization). On 02-Apr-2021, the patient experienced RASH (rash) (seriousness criterion hospitalization). In April 2021, the patient experienced SEIZURE (seizure) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PARALYSIS (paralysis) (seriousness criteria hospitalization and medically significant), PSYCHOTIC DISORDER (psychosis) (seriousness criterion hospitalization), NEUROPATHY PERIPHERAL (speaking in third tongue/neuropathy) (seriousness criteria hospitalization and medically significant), ANXIETY (anxiety) (seriousness criterion hospitalization), HYPERHIDROSIS (sweats all the time), CHEST PAIN (chest pain/chronic pain ), THIRST (he is still thirsty and takes a lot of water) and INSOMNIA (can't sleep). At the time of the report, PAIN IN EXTREMITY (pain in the arm), RASH (rash), PYREXIA (fever), SEIZURE (seizure), PARALYSIS (paralysis), PSYCHOTIC DISORDER (psychosis), NEUROPATHY PERIPHERAL (speaking in third tongue/neuropathy), ANXIETY (anxiety), HYPERHIDROSIS (sweats all the time), CHEST PAIN (chest pain/chronic pain ) and INSOMNIA (can't sleep) had not resolved and THIRST (he is still thirsty and takes a lot of water) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: rapid pulse and Irregular.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The Patient gets IVIG infusions every 3 weeks, and was under a lot of medications, but the patient caregiver did not have the list on hand but mentioned medications for psychosis. It was reported that the patient got pain in the arm and a day later the patient experienced a rash and slowly got fever, after 4 or 5 days the patient got a big seizure and all his body lost his functions and defecated everything, the patient also had paralysis, and psychosis, speaking in third tongue, the patient was in so much pain and was very thirsty, overdrinking water. Since the patient was immunocompromised they did not want to take the patient to the hospital but ended up in the hospital during 1 week, and they could not see the patient because of COVID-19 restrictions, and patient told them later that the patient was not the only one there with those conditions.  Patient visited psychiatrist and a neurologist but they did not know what the vaccine done but the patient had a neuropathy and punches the wall and even left a hole in the wall. Also the patient can't sleep and had a rapid pulse, because of what he ended up 2 times in ER. Patient had irregular heartbeats and visited a cardiologist, now the heart was completely messed up, the patient had chest pain all the time, chronic pain (but myocarditis or pericarditis have not been diagnosed so far), and sweats all the time, the patient was still thirsty and takes a lot of water but it had diminished. Patient also suffers anxiety off the charts, it changed the patient's life, the mRNA technology and the mother needs answers.  No treatment medication was reported.  Company Comment: This spontaneous case concerns a 31-year-old male patient with medical history of concurrent condition of Common Variable Immune Disease (CVID) and historical conditions of Lyme's disease with meningitis borrelia reported, who experienced unexpected serious (hospitalization) events of pain in extremity, pyrexia and rash which occurred within 2 days after receiving a dose of mRNA-1273, which was the patient's 1st dose of COVID-19 vaccination schedule. The patient also experienced unexpected serious (hospitalization, medically significant) events of seizure (AESI), paralysis, neuropathy peripheral and unexpected serious (hospitalization) events of psychotic disorder and anxiety which occurred after the same vaccination mRNA-1273 dose, but latency cannot be calculated due to events exact dates unknown. Medical history of meningitis borrelia combined with hypogammaglobulinemia(CVID) could be considered contributory factor to events of seizure (AESI), paralysis, neuropathy peripheral, psychotic disorder and anxiety. The course of events was described to start with pain in the arm on the vaccination day. A day later the patient experienced a rash and slowly got fever; after 4-5 days the patient got a big seizure (all his body lost his functions); the patient also experienced paralysis and psychosis, speaking in third tongue; was in so much pain and was very thirsty, overdrinking water. No further details regarding clinical course, etiologic and diagnostic work-up and treatment are available in the report. Events outcome was not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events' seriousness was assessed as reported.; Sender's Comments: This spontaneous case concerns a 31-year-old male patient with medical history of concurrent condition of Common Variable Immune Disease (CVID) and historical conditions of Lyme's disease with meningitis borrelia reported, who experienced unexpected serious (hospitalization) events of pain in extremity, pyrexia and rash which occurred within 2 days after receiving a dose of mRNA-1273, which was the patient's 1st dose of COVID-19 vaccination schedule. The patient also experienced unexpected serious (hospitalization, medically significant) events of seizure (AESI), paralysis, neuropathy peripheral and unexpected serious (hospitalization) events of psychotic disorder and anxiety which occurred after the same vaccination mRNA-1273 dose, but latency cannot be calculated due to events exact dates unknown. Medical history of meningitis borrelia combined with hypogammaglobulinemia(CVID) could be considered contributory factor to events of seizure (AESI), paralysis, neuropathy peripheral, psychotic disorder and anxiety. The course of events was described to start with pain in the arm on the vaccination day. A day later the patient experienced a rash and slowly got fever; after 4-5 days the patient got a big seizure (all his body lost his functions); the patient also experienced paralysis and psychosis, speaking in third tongue; was in so much pain and was very thirsty, overdrinking water. No further details regarding clinical course, etiologic and diagnostic work-up and treatment are available in the report. Events outcome was not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events' seriousness was assessed as reported.