Reporte zur Charge 02UMZUD

Symptomtext

Feel Suicidal; Brain fog; severe tinnitus; vertigo; This spontaneous case was reported by a consumer and describes the occurrence of SUICIDAL IDEATION (Feel Suicidal) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 02UMZUD) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concurrent medical conditions included Drug allergy (Fluroquinoline antibiotics). Concomitant products included ALPRAZOLAM from 02-Feb-2012 to an unknown date for Sleep disorder NOS, DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) for an unknown indication. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced TINNITUS (severe tinnitus) and VERTIGO (vertigo). On an unknown date, the patient experienced SUICIDAL IDEATION (Feel Suicidal) (seriousness criterion medically significant) and FEELING ABNORMAL (Brain fog). At the time of the report, SUICIDAL IDEATION (Feel Suicidal) outcome was unknown and FEELING ABNORMAL (Brain fog), TINNITUS (severe tinnitus) and VERTIGO (vertigo) had not resolved. It was still debilitating an had remained the same for the last 3 weeks. Doctor cleaned patient's ears and told him it was an inflammation from the vaccine, that it would go away. No treatment information provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Added new events suicidal ideation and feeling abnormal; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.