Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Bronchitis, Fatigue, Neuropathy peripheral, Suicidal ideation
Clinical narrative: tiredness; acute bronchitis; neuropathy; he was suicidal and was arrested as a result; This spontaneous case was reported by a patient and describes the occurrence of BRONCHITIS (acute bronchitis), FATIGUE (tiredness), NEUROPATHY PERIPHERAL (neuropathy) and SUICIDAL IDEATION (he was suicidal and was arrested as a result) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Johnson & Johnson Covid-19 vaccine in 2019. Past adverse reactions to the above products included No adverse event with Johnson & Johnson Covid-19 vaccine. Concurrent medical conditions included Hypertension and Chronic back pain. Concomitant products included HYDROCODONE for Chronic pain, LISINOPRIL for Hypertension.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2023, the patient experienced BRONCHITIS (acute bronchitis) (seriousness criterion hospitalization). On an unknown date, the patient experienced FATIGUE (tiredness) (seriousness criterion hospitalization), NEUROPATHY PERIPHERAL (neuropathy) (seriousness criterion medically significant) and SUICIDAL IDEATION (he was suicidal and was arrested as a result) (seriousness criterion medically significant). At the time of the report, BRONCHITIS (acute bronchitis), FATIGUE (tiredness) and NEUROPATHY PERIPHERAL (neuropathy) had not resolved and SUICIDAL IDEATION (he was suicidal and was arrested as a result) outcome was unknown.        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.   Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient reported receiving one Moderna Covid-19 vaccine in the summer of 2021. The patient reported received one Johnson & Johnson covid-19 vaccine in 2019 and stated that he had no problems with the Johnson & Johnson. Patient stated that he will be getting a CT scan soon with dye in order to see if the spike protein and T cells had been causing blood clots in his arteries. Patient stated he was diagnosed with neuropathy 6 months after receiving the Moderna Covid-19 vaccine and was experienced numbness in feet, toes and legs along with tingling and tiredness. Patient also reported acute bronchitis and stated that he has been in the emergency room six times since the summer of 2023. Patient also reported being hospitalized. Patient stated that the doctors could not figure out why he could not breathe and stated that he was started in steroids due to the difficulty breathing. The patient also stated that he was suicidal and was arrested as a result.  COMPANY COMMENT:  This is an spontaneous case concerning a 55-year-old male patient with medical history of Previously administered Janssen COVID-19 Vaccines (2 doses without adverse events), Hypertension and Chronic back pain; Concomitant products included HYDROCODONE for Chronic pain, LISINOPRIL for Hypertension who experienced  the unexpected seriousness criteria medically significant unexpected events of neuropathy peripheral, suicidal ideation; the unexpected seriousness criteria hospitalization unexpected events of bronchitis and fatigue unknown days after 1st. dose of mRNA-1273 vaccine. As the patient received doses of Janssen vaccine; "interchange of vaccine products" and "revaccination with different Covid-19 vaccine" were noted in this case. Very limited information is available for medical assessment; not enough medical history nor risk factors (only hypertension) for the events were reported; as no alternative explanation was provided, conservatively kept the events as related. The event bronchitis was assessed as not related to the vaccine due to the absence of temporal relationship. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event´s seriousness assessed as reporting and per list.; Sender's Comments: COMPANY COMMENT:  This is an spontaneous case concerning a 55-year-old male patient with medical history of Previously administered Janssen COVID-19 Vaccines (2 doses without adverse events), Hypertension and Chronic back pain; Concomitant products included HYDROCODONE for Chronic pain, LISINOPRIL for Hypertension who experienced  the unexpected seriousness criteria medically significant unexpected events of neuropathy peripheral, suicidal ideation; the unexpected seriousness criteria hospitalization unexpected events of bronchitis and fatigue unknown days after 1st. dose of mRNA-1273 vaccine. As the patient received doses of Janssen vaccine; "interchange of vaccine products" and "revaccination with different Covid-19 vaccine" were noted in this case. Very limited information is available for medical assessment; not enough medical history nor risk factors (only hypertension) for the events were reported; as no alternative explanation was provided, conservatively kept the events as related. The event bronchitis was assessed as not related to the vaccine due to the absence of temporal relationship. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event´s seriousness assessed as reporting and per list.