Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Neuropathy peripheral, Suicidal ideation
Clinical narrative: Acute bronchitis; Neuropathy/ experiencing numbness in feet, toes and legs along with tingling and tiredness; Suicidal ideation; interchange of vaccine products; Revaccination with different COVID-19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of BRONCHITIS (Acute bronchitis), NEUROPATHY PERIPHERAL (Neuropathy/ experiencing numbness in feet, toes and legs along with tingling and tiredness) and SUICIDAL IDEATION (Suicidal ideation) in a 55-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tuberculosis (Tuberculosis in the past and was about to die due to IgG4 levels being too high and the immune system was going to attack himself) and Sickness. Previously administered products included for Product used for unknown indication: Johnson & Johnson in 2019. Past adverse reactions to the above products included No adverse effect with Johnson & Johnson. Concurrent medical conditions included Multiple allergies, Chronic back pain (gets pain medicine), Blood pressure high (pressure problems) and Back injury. Concomitant products included HYDROCODONE for Chronic back pain, LISINOPRIL for Hypertension.    In 2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2023, the patient experienced BRONCHITIS (Acute bronchitis) (seriousness criterion hospitalization). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy/ experiencing numbness in feet, toes and legs along with tingling and tiredness) (seriousness criterion medically significant). an unknown date, the patient experienced SUICIDAL IDEATION (Suicidal ideation) (seriousness criterion medically significant), BLOOD IMMUNOGLOBULIN G INCREASED (IgG increased/ Elevated IgG4 levels/elevated IgG fours and spike protein in my blood/elevated levels of IgG4 and interferon), CYTOKINE INCREASED (elevated levels of IgG4 and interferon), BLOOD IRON INCREASED (elevated iron level) and ARTERIAL THROMBOSIS (Has been causing blood clots in his arteries). At the time of the report, BRONCHITIS (Acute bronchitis), NEUROPATHY PERIPHERAL (Neuropathy/ experiencing numbness in feet, toes and legs along with tingling and tiredness), BLOOD IMMUNOGLOBULIN G INCREASED (IgG increased/ Elevated IgG4 levels/elevated IgG fours and spike protein in my blood/elevated levels of IgG4 and interferon), CYTOKINE INCREASED (elevated levels of IgG4 and interferon) and BLOOD IRON INCREASED (elevated iron level) had not resolved and SUICIDAL IDEATION (Suicidal ideation) and ARTERIAL THROMBOSIS (Has been causing blood clots in his arteries) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2024, Blood immunoglobulin G: elevated. In September 2024, Blood test: blood tests reveal the presence of spike protein and interferon, indicating changes in their immune response. On an unknown date, Blood immunoglobulin G: elevated. On an unknown date, Blood iron: elevated iron levels. On an unknown date, Blood test: Blood tests show spike protein elevated and interferon levels. The patient confirmed that he conducted blood tests which resulted in high spike protein, elevated macrophage activation for interferon.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included pain medicine and high blood pressure medication. Patient conducted blood tests which resulted in high levels of IgG4, spike protein, activated macrophages, elevated Iron levels, and interferon post-vaccination with the Moderna COVID-19 Vaccine received in late 2022. The patient believed his DNA was mutated or changed as he knew what transcription was. The patient conducted a lot of research regarding Moderna vaccine with many doctors and he would continue to perform more tests. Despite exposure to various COVID-19 variants, patient had not contracted the virus. The patient noticed Moderna lowered the dose of the vaccine to keep patients safer. The patient stated that his innate immune system was strong and healthy. The patient never had a COVID-19 infection and combined with the Moderna shot he was doing very well. Patient had received the vaccine from 2022 to 2024. He added that the mRNA tells them what to do and in his case his body was producing Spike protein. The patient he saw on TV stating that the vaccine did not create Spikevax protein, but his tests show it does. The patient would perform a high-resolution scan of his lungs to see the IgG-4 levels which were elevated for two and a half years. Patient had acute bronchitis and had been in the emergency room six times since the summer of 2023. The doctors could not figure out why he could not breathe and stated that he started steroids due to the difficulty breathing. The patient almost died due to bronchitis which was treated with steroids. Two years later, he still had Spike proteins and elevated IgG-4 levels. The patient was working to detox his body from the Spike protein. He would get a CT scan soon with dye in order to see if the spike protein and T cells had been causing blood clots in arteries.  Company comment: This spontaneous case concerns a 55-year-old male patient with medical history of Tuberculosis and multiple allergies who experienced the serious (due to medically significant) unexpected events of neuropathy, suicidal ideation, the serious (due to hospitalization) unexpected event of bronchitis. The event bronchitis occurred the following year after a dose of SPIKEVAX COVID-19 VACCINE NOS, given as an unknown dose of Covid vaccination schedule and the other events occurred unknown days after a dose of SPIKEVAX COVID-19 VACCINE NOS vaccine given as an unknown dose of Covid vaccination schedule. As the patient received a dose of Janssen vaccine; "interchange of vaccine products" and "revaccination with different Covid-19 vaccine" were noted in this case. He conducted blood tests which resulted in high levels of IgG4, spike protein, activated macrophages, elevated Iron levels, and interferon post-vaccination with the Moderna COVID-19 Vaccine received in late 2022 and believed that his DNA was mutated or changed as he knew what transcription was. He conducted a lot of research regarding Moderna vaccine with many doctors and he would continue to perform more tests. The outcome of the event suicidal ideation was reported as unknown and the outcome of the rest of the events was reported as not resolved. The medical history of  tuberculosis and multiple allergies is a confounder for the event bronchitis.  In view of the long non-suggestive onset latency the causality of the event bronchitis was assessed as not related to the vaccine and likely a consequence of the medical history of tuberculosis. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-763512, US-MODERNATX, INC.-MOD-2024-774442, US-MODERNATX, INC.-MOD-2024-774425, US-MODERNATX, INC.-MOD-2024-774420, US-MODERNATX, INC.-MOD-2024-774435 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2024: Live significant follow-up received: Reporter's details, medical history, lab data and narrative were updated. On 24-Sep-2024: Live significant follow-up received: Additional reporter was added, patient's DOB and weight was added, medical history was updated, additional event of elevated iron level was added, and narrative was updated. On 25-Sep-2024: Live follow-up received contains non-significant information (narrative and reference number was updated). On 25-Sep-2024: Live follow-up received contains non-significant information (reference number was updated). On 25-Sep-2024: Live follow-up received contains no new information. On 25-Sep-2024: Live follow-up received contains non-significant information (reference number was updated).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-763512:Case for Moderna COVID-19 Vaccine US-MODERNATX, INC.-MOD-2024-774420:Same reporter US-MODERNATX, INC.-MOD-2024-774435:Same reporter US-MODERNATX, INC.-MOD-2024-774425:Same reporter US-MODERNATX, INC.-MOD-2024-774442:Same reporter